Effect of Lactobacillus GG supplementation on antibiotic-associated gastrointestinal side effects during Helicobacter pylori eradication therapy: a pilot study

BACKGROUND: One-week triple therapy is currently regarded as the reference of anti-Helicobacter pylori treatment. However, antibiotic-associated gastrointestinal side effects are among the major pitfalls of such regimens. Probiotic supplementation may be regarded as a therapeutic tool to prevent or reduce these troublesome drug-related manifestations. AIM: To determine whether the addition of the probiotic Lactobacillus GG to an anti-H. pylori standard triple therapy could help to prevent or minimize the occurrence of gastrointestinal side effects. METHODS: One hundred and twenty healthy asymptomatic subjects screened positive for H. pylori infection and deciding to receive eradication therapy were randomized either to 1-week pantoprazole (40 mg b.i.d.), clarithromycin (500 mg b.i.d.), tinidazole (500 mg b.i.d.) or to the same regimen supplemented with Lactobacillus GG for 14 days. Patients filled in validated questionnaires during follow-up to determine the type and severity of side effects and to judge overall tolerability. RESULTS: Bloating, diarrhea and taste disturbances were the most frequent side effects during the eradication week and were significantly reduced in the Lactobacillus GG-supplemented group (RR = 0.4, CI 0.2-0.8; RR = 0.3, CI 0.1-0.8; RR = 0.3, CI 0.1-0.7, respectively). The same pattern was observed throughout the follow-up period. Overall assessment of treatment tolerability showed a significant trend in favor of the Lactobacillus GG-supplemented group (p = 0.03). CONCLUSIONS: Lactobacillus GG supplementation beneficially affects H. pylori therapy-related side effects and overall treatment tolerance.     

Dual therapy using a double dose of lansoprazole with amoxicillin versus triple therapy using a double dose of lansoprazole, amoxicillin, and clarithromycin to eradicate Helicobacter pylori infection: results of a prospective randomized open study

Objectives: The eradication of Helicobacter pylori is recommended in duodenal ulcer disease. The aim of this randomized open trial was to evaluate and compare H. pylori eradication and safety after a dual therapy consisting of lansoprazole (30 mg b.i.d .) and amoxicillin (1 g b.i.d .) versus a triple therapy consisting of lansoprazole (30 mg b.i.d .), amoxicillin (1 g b.i.d .), and clarithromycin (500 mg b.i.d .) administered from day 1 to day 14.
Methods: All patients with an ulcer received lansoprazole (30 mg) from day 15 to day 28. H. pylori status was determined from antral biopsies using histology, culture, and polymerase chain reaction (PCR) upon inclusion and 1–3 months after the end of the treatment.
Results: Of the 50 patients included in the study, five did not adhere to the protocol. H. pylori eradication was obtained in 37.5% of the patients receiving lansoprazole-amoxicillin ( n = 9 /24) and in 95.2% of the patients receiving lansoprazole-amoxicillin-clarithromycin ( n = 20 /21, p < 0.0002 ). Minor side effects appeared in 8.3% of the cases during dual therapy ( n = 2 /24) and in 52% during triple therapy ( n = 13 /22, p < 0.001 ). These side effects consisted mainly of diarrhea and a metallic taste.
Conclusion: Concommitant administration of double doses of lansoprazole with amoxicillin and clarithromycin is very efficacious against H. pylori infection compared with dual therapy.     

Furazolidone, amoxicillin, bismuth and rabeprazole quadruple rescue therapy for the eradication of Helicobacterpylori

AIM： To compare the efficacy and side effect profiles of three furazolidone and amoxicillin-based quadruple rescue therapies for the eradication of Helicobacter pylori （H pylonS. METHODS： Patients who failed in the Hpylori eradication therapy for at least one course were randomly allocated into three groups. Group A received rebaprazole 10 mg＋ amoxicillin 1 g ＋ furazolidone 100 mg, and bismuth subcitrate 220 mg, twice daily for 1 wk; group B received the same regimen of group A but for 2 wk; and group C received the same regimen of group B, but furazolidone was replaced by furazolidone 100 mg three times daily. To record the side effect profiles at the end of the treatment, Hpylori eradication was assessed with 13C-urea breath test 4 wk after therapy. RESULTS： Sixty patients were enrolled including 28 males, and 20 patients in each group. The average age of the patients was 49.2 years, ranging from 18 to 84 years. H pylori eradication rates with per-protocol analysis were 82%, 89% and 90% in the three groups, respectively. Side effects were found in 11 patients, including mild dizziness, nausea, diarrhea and increased bowel movement. None of the 11 patients needed treatment for their side effects. CONCLUSION： One- or two-week furazolidone and amoxicillin-based quadruple rescue therapy with a low dose furazolidone （100 mg bid） for the eradication of Hpylori is effective. Extending the antibiotic course to 14 d could improve the eradication rates.     

Efficacy of omeprazole and amoxicillin with either clarithromycin or metronidazole on eradication of Helicobacter pylori in Chinese peptic ulcer patients

AIM: One-week triple therapy with proton pump inhibitors, clarithromycin and amoxicillin has recently been proposed as the first-line treatment for Helicobacter pylori (H pylori) infection; however, data regarding the effects of this regimen in China are scarce. The aim of this prospective and randomized study was to compare the efficacy of clarithromycin and metronidazole when they were combined with omeprazole and amoxicillin on eradication of H pylori and ulcer healing in Chinese peptic ulcer patients. METHODS: A total of 103 subjects with Hpylori-positive peptic ulcer were randomly divided into two groups, and accepted triple therapy with omeprazole 20 mg, amoxicillin 1 000 mg and either clarithromycin 500 mg (OAC group, n = 58) or metronidazole 400 mg (0AM group, n - 45). All drugs were given twice daily for 7 d. Patients with active peptic ulcer were treated with omeprazole 20 mg daily for 2-4 wk after anti-H pylori therapy. Six to eight weeks after omeprazole therapy, all patients underwent endoscopies and four biopsies (two from the antrum and two others from the corpus of stomach) were taken for rapid urease test and histological analysis (with modified Giemsa staining) to examine H pylori. Successful eradication was defined as negative results from both examination methods. RESULTS: One hundred patients completed the entire course of therapy and returned for follow-up. The eradication rate of H pylori for the per-protocol analysis was 89.3% (50/56) in OAC group and 84.1% (37/44) in 0AM group. Based on the intention-to-treat analysis, the eradication rate of H pylori was 86.2% (50/58) in OAC group and 82.2% (37/45) in 0AM group. There were no significant differences in eradication rates between the two groups on either analysis. The active ulcer-healing rate was 96.7% (29/30) in OAC group and 100% (21/21) in 0AM group (per-protocol analysis, P>0.05). Six patients in OAC group (10.3%) and five in OAM group (11.1%) reported adverse events (P>0.05). CONCLUSION: One-week triple therapy with omeprazole and amoxicillin in combination with either clarithromycin or metronidazole is effective for the eradication of H pylori. The therapeutic regimen comprising metronidazole with low cost, good compliance and mild adverse events may offer a good choice for the treatment of peptic ulcers associated with H pylori infection in China.     

Do some patients with Helicobacter pylori infection benefit from an extension to 2 weeks of a proton pump inhibitor-based triple eradication therapy?

OBJECTIVES: Seven-day proton pump inhibitor (PPI)-based triple therapies are the first-line anti-Helicobacter pylori regimens; to date, however, there is still no agreement concerning all the predictors of H. pylori cure under these regimens. The aim of this prospective study was to evaluate whether patients with certain pretreatment characteristics may benefit from an extension from 1 to 2 wk of treatment with lansoprazole, amoxycillin, and clarithromycin. METHODS: A total of 142 patients with H. pylori infection ascertained by means of gastric histopathology and 13C urea breath test (UBT) participated in this study. In all patients H. pylori density was determined at histology both on antral and corpus biopsies, and H. pylori culture with antibiotic susceptibility testing; IgG anti-H. pylori titers were also determined before therapy. Patients were randomized to receive 1-wk versus 2-wk of treatment with lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxycillin (1 g b.i.d.). The association between eradication and potential predictors was analyzed by means of unconditional logistic regression models and stratified according to the duration of treatment. A stepwise regression analysis was performed to identify variables discriminated between subjects, using eradication status as the dependent variable. RESULTS: The overall eradication rates for 1- and 2-wk treatments were 74.6% and 85.9% (intention-to-treat analysis) and 81.5% and 89.1% (per-protocol analysis), respectively (p = NS). Multivariate discriminant analysis selected as the variables independently related to eradication cigarette smoking (OR = 3.98), delta of 13C-UBT higher than 35 (OR = 9.21) and IgG anti-H. pylori titer > or = 93 (OR = 0.24) for the whole series of subjects. Stratified analysis according to the duration of therapy selected H. pylori density as the only predictor of eradication in the group treated for 1 wk (OR = 8.11). In contrast, no significant predictors were found in the group treated for 2 wk. CONCLUSIONS: Patients with a high intragastric bacterial load, as detected by histology (grade 3) or 13C-UBT (delta > 35) may benefit from an extension to 2 wk of triple therapy with lansoprazole, amoxycillin, and clarithromycin.     

The effect of probiotics on Helicobacter pylori eradication

BACKGROUND/AIMS: Conflicting results have been reported on the effect of a variety of probiotic strains on Helicobacter pylori (HP) eradication. In this study, we evaluated the outcome of a probiotic strain composed of bacillus subtilis and Streptococcus faecium on HP eradication. METHODOLOGY: We recruited 352 HP infected patients who were randomized into a triple-plus-probiotics group or a triple-only group; the participants received 1 week of PPI-based triple therapy with or without probiotics supplements. For the triple-plus-probiotics group, probiotics was continued for 8 weeks. All patients in the two groups were evaluated for 4 weeks after completion of therapy. RESULTS: Using the intention to treat analysis, evaluation of the triple-plus-probiotics group showed a higher eradication rate than the triple-only group (83.5% vs. 73.3%, p=0.027). Diarrhea and overall side effects were more common in the triple-only group (p<0.05). CONCLUSIONS: Supplementation with probiotic strains, composed of Bacillus subtilis and Streptococcus faecium, were shown to improve drug compliance, reduce side effects and enhance the intention-to-treat eradication rate of HP.     

Efficacy of 7 day lansoprazole-based triple therapy for Helicobacter pylori infection in elderly patients

BACKGROUND: The prevalence of Helicobacter pylori increases with age. However, data regarding the effects of anti-H. pylori treatments in the elderly are very scarce. METHODS: To evaluate the effect of three lansoprazole-based, 7 day, triple-therapy regimens on H. pylori eradication rates, symptomatology, chronic gastritis activity and serological markers of H. pylori infection in elderly subjects, we studied 150 symptomatic patients over 60 years of age with H. pylori-positive duodenal ulcer (DU, n = 34), gastric ulcer (GU, n= 19) or chronic gastritis (CG, n = 97). Patients were consecutively treated with one of the following regimens: (A) lansoprazole (LNS) 30 mg b.i.d. + clarithromycin (CLR) 250 mg b.i.d. + metronidazole (MTR) 250 mg q.i.d.; (B) LNS 30mg b.i.d. + amoxycillin (AMOX) 1 g b.i.d. + MTR 250 mg q.i.d.; and (C) LNS 30 mg b.i.d. + CLR 250 mg b.i.d. + AMOX 1 g b.i.d. RESULTS: Two months after therapy, the eradication rates of the three treatments, expressed using both intention-to-treat and per-protocol analyses were, respectively; group A, 86 and 91.5%; group B, 80 and 87%; group C, 82 and 89.1%. After therapy, a significant reduction in epigastric pain (P<0.001), heartburn (P=0.02), dyspepsia (P<0.001) and vomiting (P< 0.005) was observed independently of the success of H. pylori eradication. A significantly higher percentage of asymptomatic patients were in the GU-DU group than in CG group (87.7 vs 70.0%, P= 0.032). After therapy, 33 subjects still suffered from symptoms. Persistence of symptoms was significantly associated with an endoscopic diagnosis of oesophagitis and not with H. pylori infection. Patients cured of H. pylori infection showed a significant decrease in the histological activity of both antral and body gastritis (P< 0.0001), a significant drop in immunoglobulin (Ig) G anti-H. pylori antibodies (P< 0.0001) and pepsinogen (PG) C (P<0.0001) and an increase in the PGA/PGC ratio (P<0.0001). CONCLUSIONS: The 7 day, lansoprazole-based triple therapy was well tolerated and highly effective in the cure of H. pylori infection, the reduction of symptoms, chronic gastritis activity and serum levels of IgG anti-H. pylori antibodies and PGC. Persistence of symptoms after therapy was significantly higher in CG than GU and DU patients and was significantly associated with oesophagitis.     

Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study

GOALS: To determine the efficacy of triple therapy supplemented with a specially designed fermented milk product containing specific probiotic Lactobacillus casei (L. casei) DN-114 001 strain on Helicobacter pylori eradication in children. BACKGROUND: Lactobacillus species possess in vitro activity against H. pylori. There are no consistent data on the impact of eradication therapy supplemented with probiotics on H. pylori cure rates in childhood in vivo. STUDY: Multicenter, prospective, randomized, double-blind controlled study. Eighty-six symptomatic H. pylori-positive children were randomized either to receive the control treatment of omeprazole, amoxicillin, and clarithromycin (OAC) for 7 days or the test treatment of omeprazole, amoxicillin, and clarithromycin for 7 days supplemented with fermented milk (Actimel) containing L. casei DN-114 001 (OAC-LC), for 14 days. H. pylori status was assessed at 4 weeks following therapy using two noninvasive tests. RESULTS: Intention-to-treat (ITT) based eradication rates for the OAC-LC group were 84.6% (95% CI, 71.2%-95.5%), and 91.6% (95% CI, 76.9%-98.2%) by per-protocol (PP) analysis. Eradication in the OAC group was 57.5% (95% CI, 42.2%-72.3%) in the ITT set and 61.3% (95% CI, 44.4%-75.0%) in the PP group. Eradication success was higher in the OAC-LC group compared with the OAC group in both ITT (P=0.0045) and PP analysis (P=0.0019). Primary resistance for clarithromycin could be determined in 21.2%. Side effects were infrequent. Drug compliance was good throughout the study. CONCLUSION: Supplementation with fermented milk, containing live special probiotic L. casei DN-114 001, confers an enhanced therapeutic benefit on H. pylori eradication in children with gastritis on triple therapy.     

The effect of intragastric acidity on Helicobacter pylori eradication with bismuth-metronidazole-amoxicillin.

BACKGROUND/AIMS: Adding an acid secretion inhibitor to anti-H. pylori regimens may be potentially valuable for enhancing the effectiveness of antimicrobials that exhibit markedly reduced activity at low pH. This study was conducted to evaluate intragastric acidity as a factor in H. pylori eradication with bismuth-based triple therapy. METHODOLOGY: Forty patients with duodenal ulcer and H. pylori infection were included. The patients were divided into 2 groups--normacid (n = 20) and hyperacid (n = 20)--based on the amount of time that 24-hour intragastric pH took to reach the level pH > or = 3. All patients received bismuth subsalicylate (600 mg 3 times daily), metronidazole (500 mg 3 times daily) and amoxicillin (500 mg 3 times daily) for 2 weeks. Then, all patients continued treatment with ranitidine (150 mg twice daily) for 8 weeks prior to the follow-up examination. Blood samples were collected before treatment for measurement of fasting gastrin and pepsinogen-I. RESULTS: Nine patients (45%) in the normacid group and 8 patients (40%) in the hyperacid group reported side effects. However, there were only 2 patients (10%) in each group who withdrew from the study due to intolerance of side-effects. There was no difference in the H. pylori eradication rate between the normacid and hyperacid groups (16/18, 88.9% vs. 15/18, 83.3%). CONCLUSIONS: Without co-administration of anti-secretary agents, intragastric acid is not a significant factor in the effectiveness of H. pylori eradication with bismuth-based triple therapy.     

Probiotic monotherapy and Helicobacter pylori eradication: A systematic review with pooled-data analysis

AIM To define probiotic monotherapy effect on Helicobacter pylori(H. pylori) status by performing a systematic review.METHODS Methods of analysis and inclusion criteria were based on PRISMA recommendations. Relevant publications were identified by searching Pub Med, MEDLINE, Science Direct, and EMBASE. The end-point was to estimate eradication rate and urea breath test delta value before and after probiotic monotherapy across all studies and, overall, with a pooled data analysis. Adverse events of probiotic therapy were evaluated. The data were expressed as proportions/percentages, and 95%CIs were calculated. For continuous variables, we evaluated the weighted mean difference. Odd ratios(ORs) were calculated according to the Peto method for the comparison of eradication rates between probiotics and placebo.RESULTS Eleven studies were selected. Probiotics eradicated H. pylori in 50 out of 403 cases. The mean weighted eradication rate was 14%(95%CI: 2%-25%, P =0.02). Lactobacilli eradicated the bacterium in 30 out of 235 patients, with a mean weighted rate of 16%(95%CI: 1%-31%). Saccharomyces boulardii achieved eradication in 6 out of 63 patients, with a pooled eradication rate of 12%(95%CI: 0%-29%). Multistrain combinations were effective in 14 out of 105 patients, with a pooled eradication rate of 14%(95%CI: 0%-43%). In the comparison of probiotics vs placebo, we found an OR of 7.91 in favor of probiotics(95%CI: 2.97-21.05, P 0.001). Probiotics induced a mean reduction in delta values higher than placebo(8.61% with a 95%CI: 5.88-11.34, vs 0.19% for placebo, P 0.001). Finally, no significant difference in adverse events was found between probiotics and placebo(OR = 1, 95%CI: 0.06-18.08).CONCLUSION Probiotics alone show a minimal effect on H. pylori clearance, thus suggesting a likely direct role.     

Enhancing compliance not a prerequisite for effective eradication of Helicobacter pylori: the HelP Study

OBJECTIVE: The aim of this study was to compare cure rates of Helicobacter pylori (H. pylori) infection, compliance, and side effects in patients given 10 days of omeprazole 20 mg b.d., amoxycillin 500 mg t.d.s., and metronidazole 400 mg t.d.s. (OAM) or 10 days OAM plus compliance enhancing measures. METHODS: A total of 119 H. pylori-positive patients were prospectively randomized to receive either 10 days OAM or 10 days OAM plus compliance enhancing measures (medication in a dose dispensing unit, medication chart, an information sheet about H. pylori treatment, and phone call 2 days after starting therapy). H. pylori eradication was assessed by 13C-UBT at least 4 wk after cessation of therapy, compliance by phone interview on the last day of therapy and returned pill count, and side effects by phone interview and returned side effects form. RESULTS: In 113 patients attending 13C-UBT H. pylori was eradicated in 51 of 57 patients (89.5%) after 10 days OAM and in 48 of 56 (85.7%) after 10 days OAM plus compliance enhancing measures (p = 0.54). In both groups 97% of medications were taken. Side effects were common (82% of patients). Both side effects (p = 0.001) and ulcer versus nonulcer at endoscopy (p = 0.016) were independent predictors of treatment failure; side effects also predicted noncompliance (p = 0.02). CONCLUSIONS: Ten days of OAM was effective for H. pylori eradication in our clinical population. Patient compliance was excellent and attempts to increase compliance had no impact on outcome or compliance. Side effects were very common and were significantly associated with treatment failure and decreased compliance.     

Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: a prospective randomized trial

AIM: To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori(H. pylori) infection.METHODS: From March 2013 to May 2014,one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before wererandomized to receive either sequential therapy(rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d,followed by rabeprazole 20 mg,clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy(rabeprazole 20 mg and amoxicillin 1 g for 7 d,followed by rabeprazole 20 mg,amoxicillin 1 g,clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy,or 13C-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intension-to-treat(ITT) and per-protocol(PP) analyses.RESULTS: One hundred and sixty-seven patients(83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups,respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis(P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis(P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.CONCLUSION: Due to a grade A( 95%) success rate for H. pylori eradication by PP analysis,similar compliance and adverse events,hybrid therapy seems to be an appropriate eradication regimen in Taiwan.     

Omeprazole-based triple therapy with low-versus high-dose of clarithromycin plus amoxicillin for H pylori eradication in Iranian population

AIM: To investigate the efficacy and tolerability of H pylori eradication in an omeprazole-based triple therapy with high-and low-dose of clarithromycin and amoxicillin. METHODS: One hundred and sixty H pylori positive patients were randomly assigned to two groups based on the following 2 wk investigation; (1) group A or low-dose regimen received omeprazole 20 mg b.i.d, clarithromycin 250 mg b.i.d and amoxicillin 500 mg b.i.d; and (2) group B or high-dose regimen received omeprazole 20 mg b.i.d, clarithromycin 500 mg b.i.d and amoxicillin 1000 mg b.i.d. During the study H pylori status was assessed by histology and rapid urease test prior and by 13C-urea breath test 6 wk after the therapy. Standard questionnaires were administered to determine the compliance to treatment and possible adverse events of therapy. Data were subject to χ2 to compare the eradication rates in the two groups. The significant level of 95% (P ≤ 0.05) was considered statistically different. RESULTS: We found that the per-protocol eradication rate was 88% (68/77) in group A, and 89% (67/75) in group B. The intension-to-treat eradication rate was 85% (68/80) in group A and 83.75% (67/80) in group B. Overall adverse events were 26% in group A and 31% in group B. The adverse events were generally mild in nature and tolerated well in both groups with a compliance of 98% in group A vs 96% in group B. CONCLUSION: The omeprazole-based low dose regimen of clarithromycin and amoxicillin for two weeks in H pylori eradication is as effective as high dose regimen in Iranian population.     

Limited Efficacy of Omeprazole-based Dual and Triple Therapy for Helicobacter pylori: A Randomized Trial Employing "Optimal" Dosing

Objectives: To evaluate the efficacy and side effects of dual omeprazole/amoxicillin therapy for Helicobacter pylori given in "optimal" fashion (omeprazole twice a day, 3 g of amoxicllin daily, drugs started concurrently, 2 wk of therapy) and to assess the utility of adding a second antibiotic, tetracyline. Methods: Sixty healthy volunteers with H. pylori infection documented by ¹³C-urea breath test were randomly assigned to receive 2 wk of therapy with either 1) omeprazole 20 mg b.i.d. and amoxicillin 1 g t.i.d. (OA), or 2) OA plus tetracycline 500 mg t.i.d. (OAT). Patients returned after 2 wk for pill count and clinical assessment, and "C-urea breath test was repeated 4 wk after the end of therapy. Results: H. pylori was eradicated in 15 (50%) of 30 patients receiving OA therapy and in nine (30%) of 30 given OAT ( p = 0.19). Side effects occurred in five (17%) patients in the OA group [two (7%) discontinued therapy due to side effects] and eight (27%) of the OAT group [three (10%) stopped therapy due to side effects]. Good compliance (>80% of prescribed study drugs taken) was seen in 87% of each group, and eradication rates were 54% and 35% among patients with good compliance in the OA and OAT groups ( p = 0.26). Conclusions: Dual therapy with omeprazole and amoxicillin, when given in "optimal" fashion, had limited efficacy, with an eradication rate of 50%. The addition of tetracycline to the dual therapy did not improve the rate of cure. Because virtually all of our subjects were from minority groups, with over three-fourths Hispanic, we speculate that differences in H. pylori strains or host factors may explain, at least in part, the discrepancy between our results and those in Northern European populations.     

Lactobacillus ruteri compared with placebo as an adjuvant in quadruple therapy for Helicobacter pylori eradication: A randomized,double-blind,controlled trial

Background and study aimsThe aim of this study was to evaluate the efficacy of probiotic as an adjuvant in quadruple therapy for H. pylori eradication compared with placebo.Patients and methodsThis randomized, double-blind, controlled trial was conducted on 450 patients with confirmed H. pylori infection. We randomly allocated patients (1:1) to receive probiotic (Lactobacillus ruteri, 100 mg) or placebo as an adjuvant in quadruple therapy with bismuth subcitrate 240 mg, pantoprazole 40 mg, amoxicillin 1000 mg and clarithromycin 500 mg all twice daily for 14 days. The primary outcome of the study was the H. pylori eradication rate at eight weeks after the end of treatment using ¹⁴C-urea breath test. The secondary endpoint of study was patient-reported side effects of drugs. The study protocol was approved by the Iranian Registry of Clinical Trials (IRCT20080901001155N32).ResultsH. pylori eradication rates were higher in the probiotic group, compared to placebo, but this difference was not statistically significant, according to both intention-to-treat (78.7 % (95 % CI; 71.24–86.16) versus 72 % (95 % CI; 64.9–79.1), respectively) and per-protocol (80.1 % (95 % CI; 73.7 – 86.5) versus 75.2 %(95 % CI; 68.4 – 82), respectively). About 69.7 % of patients in the probiotic group experience side effects compared to 98.6 % in the placebo group that was statistically significant (P-value < 0.001). Headache and all gastrointestinal adverse events except constipation were significantly lower in the probiotic group compared to placebo (P-value < 0.001).ConclusionAdding Lactobacillus ruteri to quadruple therapy did not significantly improve the eradication of H. pylori. However it reduced the frequency of drug-associated side effects.     

Lactobacillus ruteri compared with placebo as an adjuvant in quadruple therapy for Helicobacter pylori eradication: A randomized,double-blind,controlled trial

Background and study aimsThe aim of this study was to evaluate the efficacy of probiotic as an adjuvant in quadruple therapy for H. pylori eradication compared with placebo.Patients and methodsThis randomized, double-blind, controlled trial was conducted on 450 patients with confirmed H. pylori infection. We randomly allocated patients (1:1) to receive probiotic (Lactobacillus ruteri, 100 mg) or placebo as an adjuvant in quadruple therapy with bismuth subcitrate 240 mg, pantoprazole 40 mg, amoxicillin 1000 mg and clarithromycin 500 mg all twice daily for 14 days. The primary outcome of the study was the H. pylori eradication rate at eight weeks after the end of treatment using ¹⁴C-urea breath test. The secondary endpoint of study was patient-reported side effects of drugs. The study protocol was approved by the Iranian Registry of Clinical Trials (IRCT20080901001155N32).ResultsH. pylori eradication rates were higher in the probiotic group, compared to placebo, but this difference was not statistically significant, according to both intention-to-treat (78.7 % (95 % CI; 71.24–86.16) versus 72 % (95 % CI; 64.9–79.1), respectively) and per-protocol (80.1 % (95 % CI; 73.7 – 86.5) versus 75.2 %(95 % CI; 68.4 – 82), respectively). About 69.7 % of patients in the probiotic group experience side effects compared to 98.6 % in the placebo group that was statistically significant (P-value < 0.001). Headache and all gastrointestinal adverse events except constipation were significantly lower in the probiotic group compared to placebo (P-value < 0.001).ConclusionAdding Lactobacillus ruteri to quadruple therapy did not significantly improve the eradication of H. pylori. However it reduced the frequency of drug-associated side effects.     

Effects of multistrain probiotic-containing yogurt on second-line triple therapy for Helicobacter pylori infection

Background and Aims: The adjuvant effects of probiotic‐containing yogurt on second‐line triple therapy for Helicobacter pylori (H. pylori) infection have not been evaluated. Methods: A total of 337 patients with persistent H. pylori infection, after first‐line triple therapy, were randomly assigned to receive either triple therapy with (yogurt group, n = 151) or without (control group, n = 186) Will yogurt. Triple therapy consisted of 400 mg moxifloxacin q.d., 1000 mg amoxicillin b.i.d., and 20 mg esomeprazole b.i.d. for 14 days. Will yogurt contains Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium longum, and Streptococcus thermophilus. H. pylori eradication was evaluated by the ¹³C‐urea breath test, histology, or the rapid urease test. Results: The eradication rates by intention‐to‐treat analysis were 66.7% and 68.9% in the control and yogurt groups, respectively (P = 0.667). The eradication rates by per‐protocol analysis were 78.5% and 86% in the control and the yogurt groups, respectively (P = 0.110). The adverse event rates were 25.3% and 28.5% in the control group and yogurt group, respectively (P = 0.508). Conclusions: The addition of yogurt containing probiotics to moxifloxacin‐containing second‐line treatment neither improved H. pylori eradication rates nor reduced the adverse events of treatment.     

Cure of Helicobacter pylori Infection: Role of Duration of Treatment with Omeprazole and Amoxicillin

Objectives : To date, some studies have suggested that short-term therapy may be a promising therapeutic concept for the eradication of Helicobacter pylori . The primary objective of the present study was to elucidate the role of the duration of treatment in the cure of H. pylori infection. Methods : Forty consecutive patients with H. pylori -positive peptic ulcer disease were randomly allocated to four study groups. The groups were treated with a 14-day course of 20 mg omeprazole b.i.d. orally combined with 2 g amoxicillin t.i.d. intravenously for 1 day (n = 10; six women, age range 40–84 yr), for 3 days (n = 10; three women, age range 29–74 yr), for 5 days (n = 10; five women, age range 21–82 yr), and for 7 days (n = 10; five women, age range 42-82 yr), respectively. Initially, a standardized clinical evaluation of symptoms and an upper GI tract endoscopy were performed for assessment of H. pylori infection of the gastric mucosa (biopsy urease test, specific culture, and histology). At least 4 wk after cessation of omeprazole medication, H. pylori eradication was evaluated either as described or with the help of the ³¹C-urea breath test. Results: H. pylori eradication, defined as negative bacterial findings in urease test, culture, and histology or ³¹C-urea breath test at least 4 wk after discontinuation of omeprazole therapy, was achieved in one of 10 patients (10%) in the one-day group, none of 10 patients (0%) in the 3- and 5-day groups and six of 10 patients (60%) in the 7-day group. Conclusions : We conclude that short-term therapies with the proton pump inhibitor omeprazole and the antibiotic amoxicillin must be considered completely ineffective if performed as a short-term therapy for up to 5 days. A therapy duration of 7 days seems to mark a turning point in antibiotic effectiveness, with a rapid increase in eradication rates.     

Are probiotics useful in Helicobacter pylori eradication?

Helicobacter pylori(H. pylori) is considered an etiologic factor for the development of peptic ulcer disease,gastric adenocarcinoma, and MALT lymphoma.Therapeutic schemes to eradicate the bacteria are based on double antibiotic therapy and proton pump inhibitor. Despite many therapeutic improvements in H. pylori eradication treatment, it is still associated with high infection rate also in developed countries.Bacterial resistance and adverse events occurrence are among most frequent causes for anti- H. pylori treatment failure. Several studies have reported that certain probiotic strains can exhibit inhibitory activity against H. pylori bacteria. In addition, some probiotic strains can reduce the occurrence of side effects due to antibiotic therapy and consequently increase the H.pylori eradication rate. The results of the prospective double-blind placebo-controlled studies suggest that specific probiotics, such as S. boulardii and L.johnsonni La1 probably can diminish the bacterial load,but not completely eradicate the H. pylori bacteria.Furthermore, it seems that supplementation with S. boulardii is a useful concomitant therapy in the standard H. pylori eradication treatment protocol and most probably increases eradication rate. L. reuteri is equally effective, but more positive studies are needed. Finally, probiotic strains, such as S. boulardii,L. reuteri and L. GG, decrease gastrointestinal antibiotic associated adverse effects.     

Low Dose, Short-Term Triple Therapy for Cure of Helicobacter pylori Infection and Healing of Peptic Ulcers

Objectives: The aim of this study was to confirm the efficacy and tolerability of a new, low dose, short-term triple therapy for cure of Helicobacter pylori infection, as suggested by Bazzoli, in a larger population. Methods: On an "intention-to-treat" basis, 116 patients with active (n = 41) or healed (n = 47) peptic ulcer disease or ulcer-like dyspepsia (n = 28) and H. pylori infection received a 1-wk course of omeprazole 20 mg b.i.d. , clarythromycin 250 mg b.i.d. , and tinidazole 500 mg b.i.d. , Four weeks after treatment withdrawal, cure of H. pylori infection was evaluated by rapid urease test and histology. Results: One hundred and sixteen patients returned for follow-up. In 108 patients, H. pylori could not be identified 4 wk after cessation of therapy. The eradication rate was calculated to 93%. In addition, all patients with active peptic ulcers showed complete healing at follow-up despite no further treatment. Drug acceptance and compliance was excellent. Conclusion: Triple therapy as suggested by Bazzoli with omeprazole (in this study given b.i.d. for better compliance), clarythromycin, and tinidazole is indeed highly effective for both cure of H. pylori infection and for healing of peptic ulcers, is easy to perform, is cheap, and is without clinically significant side effects, even in a larger population.