The use of cimetidine in newborns

Cimetidine, a specific H2 antagonist and a potent inhibitor of gastric secretion, was administered in newborns who failed to tolerate oral feeding and presented with abnormal gastric residues accompanied by microscopic or macroscopic high gastrointestinal bleeding. This group of 18 infants was compared to a control group of 15 in similar clinical conditions. After 4 days of treatment with cimetidine (24 mg/kg/day), adapted oral alimentation generally was well tolerated with normal gastric residues. No side effects of the therapy were observed.     

Cisapride decreases prolonged episodes of reflux in infants

Twenty-nine infants (2-4 months old), with pathological gastroesophageal reflux assessed by 24-h esophageal pH monitoring, were studied. Cisapride or placebo was randomly added to positional treatment, prone-antiTrendelenburg position, which was applied to all infants. The pH monitoring was repeated after 13-16 days of treatment and revealed a significant improvement in both groups for most parameters. But the number of reflux episodes lasting longer than 5 min and the total number of reflux episodes had not decreased significantly in the placebo group. Only in the number of reflux episodes lasting longer than 5 min was improvement during treatment significantly greater in the cisapride group. This suggests cisapride both prevented reflux and improved esophageal clearance. These results suggest that in addition to other therapeutic measurements, such as positional treatment (which was previously demonstrated to be effective in this age group), cisapride might be of benefit in the treatment of gastroesophageal reflux disease.     

Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti^®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti^®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.     

Contribution of the 13C-urea breath test to the detection of Helicobacter pylori gastritis in children.

Serology, 13C-urea breath test, histology, Campylobacter-like organism testing, and culture were performed in 95 consecutive children to evaluate the contribution of these tests to the detection of Helicobacter pylori infection. In analyses considering any combination of three positive tests as "gold standard" for diagnosing H pylori infection, 26 children were Helicobacter positive (27%), which is only one patient more than the number of children with only a positive culture. The accuracy of culture was excellent when "any combination of three positive tests" was used as the gold standard (sensitivity 96%, specificity 100%, positive predictive value 100% [false positivity 0%], negative predictive value 99% [false-negative results 1%]). The results of invasive and noninvasive tests were comparable. When culture was considered as "gold standard," the sensitivity of serology and 13C-urea breath test was 96%; the specificity was 96% and 93%, respectively; the positive predictive value was 89% and 83% (false-positive results in 11% and 17%); and the negative predictive value for both was 99% (false-negative results in 1%). It is concluded that culture can be used as gold standard, but that non-invasive tests such as serology and/or 13C-urea breath test can be used to diagnose H pylori infection in children, since each has at least 95% sensitivity and 92% specificity.     

The role of Helicobacter pylori in paediatrics

Helicobacter pylori is a bacterium that colonizes the human stomach, especially during childhood. Although it has been studied intensively during the past decade, many controversies still exist on many important issues, including the clinical relevance of virulence factors, indications for treatment, recommended procedures for diagnosis and the typical symptom profile, among others. The lack of double-blind, placebo-controlled studies in children illustrates the paucity of hard scientific data, and is the major reason for differences in opinion. Therefore, the present review of literature published during the past 2 years raises many questions.     

Gastro-oesophageal reflux in infancy

Gastro-oesophageal reflux (GOR) is a common phenomenon in infants, which may occur with or without accompanying symptoms. Although most infants presenting with regurgitation have a normal physical examination, it is now recognized that infants may also present with a wide variety of symptoms. Oesophagitis is associated with increased oesophageal acid exposure. The determination of cause and effect is difficult, as there are many aspects of reflux disease where cause and effect relationships are cyclic. Reflux disease is present when there is an imbalance between a number of factors that can contribute to a decrease, as well as an increase, of GOR. Oesophageal pH monitoring with a semi-disposable monocrysant antimony pH catheter with three sensors is very good at documenting oesophageal acidification and gastric buffering and, therefore, quantifies acid reflux frequency and duration. However, the interpretation of the data is complex as they are influenced by numerous factors, such as position, activity (sleep, crying), feeding (frequency and composition) or medication. The duration of buffering of gastric acidity during pH monitoring might, in the future, appear to be a relevant factor in the interpretation of oesophageal pH data.     

Locust bean gum safety in neonates and young infants: An integrated review of the toxicological database and clinical evidence

Locust bean gum (LBG) is a galactomannan polysaccharide used as thickener in infant formulas with the therapeutic aim to treat uncomplicated gastroesophageal reflux (GER). Since its use in young infants below 12 weeks of age is not explicitly covered by the current scientific concept of the derivation of health based guidance values, the present integrated safety review aimed to compile all the relevant preclinical toxicological studies and to combine them with substantial evidence gathered from the clinical paediatric use as part of the weight of evidence supporting the safety in young infants below 12 weeks of age. LBG was demonstrated to have very low toxicity in preclinical studies mainly resulting from its indigestible nature leading to negligible systemic bioavailability and only possibly influencing tolerance. A standard therapeutic level of 0.5 g/100 mL in thickened infant formula is shown to confer a sufficiently protective Margin of Safety. LBG was not associated with any adverse toxic or nutritional effects in healthy term infants, while there are limited case-reports of possible adverse effects in preterms receiving the thickener inappropriately. Altogether, it can be concluded that LBG is safe for its intended therapeutic use in term-born infants to treat uncomplicated regurgitation from birth onwards.