The eradication of Helicobacter pylori to prevent gastric cancer: a critical appraisal

Introduction: Gastric cancer is one of the top causes of cancer-related death worldwide. How to eliminate gastric cancer is an urgent public-health issue.

Areas covered: In this review, we present up-to-date results of studies on gastric cancer prevention through the eradication of Helicobacter pylori and discuss strategies and obstacles for the implementation of population-wide screening and treatment of this pathogen to prevent gastric cancer.

Expert commentary: Gastric cancer is an inflammation-associated cancer with multistep carcinogenesis. The process consists of H. pylori infection, ongoing inflammation, development of metaplastic epithelia and genetic instability eventuating in gastric cancer. H. pylori infection is critical for development of the disease and studies have consistently shown that H. pylori eradication results in a reduction in (a) gastric mucosal inflammation, (b) progression of histologic damage, (c) risk of peptic ulcers and ulcer recurrence, and (d) risk of gastric cancer. Compared with a large number of clinical trials evaluating chemopreventive approaches, studies of population-wide screening, and eradication of H. pylori have only recently begun and only in high-risk populations. To eliminate gastric cancer requires information on how to implement an effective program for screening and treatment of H. pylori taking into consideration the other health priorities in any specific population.     

Advance Care Planning Program and the Knowledge and Attitude Concerning Palliative Care

Objectives: The study aimed to evaluate the effects of an advance care planning (ACP) program on knowledge and attitudes concerning palliative care, and decisions regarding DNR orders in the older residents in a long-term care institution.

Methods: A quasi-experimental design was used. Participants were cognitively unimpaired older residents in a long-term care institution in Taiwan. The experimental group (n = 29) received the intervention including an individual interview using an ACP handbook and a group patient education; whereas the control group (n = 28) received the group patient education only.

Results: There were significant positive effects of the ACP program on understanding of DNR and palliative care, willingness to sign a DNR order, and knowledge of and attitude towards palliative care; however, there was no significant effect on willingness to receive palliative care. Six participants signed the DNR order after the intervention compared to none in the control group.

Conclusions: The ACP program can improve knowledge and attitudes towards palliative care in older residents in long-term care institutions.

Clinical Implications: The ACP program could incorporate multiple components, including individual interview using ACP handbook and group patient education, and address knowledge and attitudes towards palliative care.     

Depression and risky alcohol use: an examination of the role of difficulties regulating positive emotions in trauma-exposed individuals

Background: The co-occurrence of depression and risky alcohol use is clinically relevant given their high rates of comorbidity and reciprocal negative impact on outcomes. Emotion dysregulation is one factor that has been shown to underlie this association. However, literature in this area has been limited in its exclusive focus on emotion dysregulation stemming from negative emotions.

Objectives: The goal of the current study was to extend research by exploring the role of difficulties regulating positive emotions in depression symptom severity, risky alcohol use, and their association.

Methods: Participants were 395 trauma-exposed adults recruited from Amazon’s Mechanical Turk (MTurk) platform (56.20% female, M_age = 35.55) who completed self-report questionnaires.

Results: Zero-order correlations among depression symptom severity, the three subscales of difficulties regulating positive emotions, and risky alcohol use were positive. Two subscales of difficulties regulating positive emotions—nonacceptance of positive emotions and difficulties controlling impulsive behavior when experiencing positive emotions—accounted for the relationship between depression symptom severity and risky alcohol use.

Conclusion: Results suggest the importance of incorporating techniques focused on improving positive emotion regulation skills in interventions for risky alcohol use among individuals with depression.     

Urban–rural environmental exposure during childhood and subsequent risk of inflammatory bowel disease: a meta-analysis

Background: The relationship between living conditions in urban and rural areas during childhood and subsequent inflammatory bowel disease (IBD) remains controversial.

Aim: To explore the association between environmental exposures early in life and the subsequent risk of IBD.

Methods: Literature searches were conducted in the following databases: PubMed, EMBASE, and Conference Proceedings Citation Index. Studies were analyzed separately using rate ratios (RRs) or odds ratios (ORs) with 95% confidence intervals.

Results: The search strategy identified 15 studies. Of these, 9 studies explored the association between urban exposure during childhood and ulcerative colitis (UC), and 12 and 4 studies explored this relationship with Crohn’s disease (CD) and IBD, respectively. A meta-analysis showed that the pooled ORs estimated for the case–control studies of UC, CD, and IBD were 1.16 (0.83, 1.61), 1.45 (1.45, 1.85), and 1.34 (1.11, 1.62), respectively. The pooled RR estimated for the cohort studies of CD and IBD was 1.48 (1.17, 1.87). The stratified analysis and meta-regression showed significant relationships between CD and living conditions in case–control studies published during 2010–2017 and in non-European countries (P < 0.05).

Conclusions: Living conditions during childhood are positively associated with the subsequent development of IBD. Urban living environment is more common among those with CD than UC.     

The Role of Cultural and Family Values on Social Connectedness and Loneliness among Ethnic Minority Elders

Objectives: Ethnic minority elders have high levels of social isolation and loneliness. Assumptions about the family providing enough social support exist in the literature, contradicting ethnic minority elders’ reported levels of isolation and loneliness. While structural barriers influence feelings of isolation and loneliness, limited information exists about the role of cultural factors such as acculturation and family values. Accordingly, this study investigated the roles of acculturation and family values on loneliness and social isolation among ethnic minority elders.

Methods: Ethnic minority elders (N = 123) completed a questionnaire that assessed their social connectedness, measured by social network and levels of loneliness, and structural factors such as income. Additionally, cultural and family values were assessed by acculturation and the ‘family as referents’ dimension of familism, which refers to the belief that family members’ behaviour should meet with familial expectations.

Results: Statistical analysis using hierarchical regression indicated that ‘family as referents’ and acculturation predicted loneliness, but not social network.

Conclusions: This study raises the importance of considering cultural values when investigating predictors of loneliness among ethnic minority elders.

Clinical Implications: Findings highlight the importance of addressing familial expectations in programs aimed at alleviating loneliness among ethnic minority elders.     

Reference intervals of aortic pulse wave velocity assessed with an oscillometric device in healthy children and adolescents from Argentina

Age-related reference intervals (RIs) of aortic pulse wave velocity (Ao-PWV) obtained from a large healthy population are lacking in South America. The aims of this study were to determine Ao-PWV RIs in a cohort of healthy children and adolescents from Argentina and to generate year-to-year percentile curves.

Ao-PWV was measured in 1000 healthy subjects non-exposed to traditional cardiovascular risk factors (Age: 10–22 y. o., 56% males). First, we evaluated if RIs for males and females were necessaries (correlation and covariate analysis). Second, mean (M) and standard deviation (SD) age-related equations were obtained for cf-PWV, using parametric regression methods based on fractional polynomials. Third, age-specific (year to year) percentiles curves (for all, males and females children and adolescents) were generated using the standard normal distribution. They were, age-specific 1st, 2.5th, 5th, 10th, 25th, 50th, 75th, 90th, 95th, 97.5th and 99th percentile curves and values.

After covariate analysis (i.e., adjusting by age, jugulum-symphysis distance, body weight and height), specific RIs for males and females of children and adolescents were evidenced as necessaries. The equations were

For all subjects:

Ao-PWV_Mean = 4.98 + 12.86x10^?5 Age³.

Ao-PWV_SD = 0.47 + 21.00x10^?6Age³.

For girls:

Ao-PWV_Mean = 5.07 + 10.23x10^?5Age³.

Ao-PWV_SD = 0.50 + 10.00x10^?6Age³.

For boys:

Ao-PWV_Mean = 4.87 + 15.81x10^?5Age³.

Ao-PWV_SD = 0.46 + 22.34x10^?6Age³.

Our study provides the largest database to-date concerning Ao-PWV in healthy children and adolescents in Argentina. Age-related equations (M and SD values) for Ao-PWV are reported by the first time. Specific RIs and percentiles of Ao-PWV are now available according to age and sex for an Argentinian population.     

Modelling the role of microbial p-cresol in colorectal genotoxicity

Background: A greater understanding of mechanisms explaining the interactions between diet and the gut microbiota in colorectal cancer is desirable. Genotoxic microbial metabolites present in the colon may be implicated in carcinogenesis and potentially influenced by diet.

Aims: We hypothesised that microbial p-cresol is a colonic genotoxin and set out to model potential exposures in the colon and the effects of these exposures on colonic cells.

Methods: Batch culture fermentations with human faecal inoculate were used to determine the synthesis of p-cresol and other metabolites in response to various substrates. The fermentation supernatants were evaluated for genotoxicity and the independent effects of p-cresol on colonic cells were studied in vitro.

Results: In batch culture fermentation, supplementary protein increased the synthesis of phenols, indoles and p-cresol, whereas supplementary fructoligosaccharide (FOS) increased the synthesis of short chain fatty acids. The p-cresol was the greatest predictor of genotoxicity against colonocytes in the fermentation supernatants. Spiking fermentation supernatants with exogenous p-cresol further increased DNA damage, and independently p-cresol induced DNA damage in a dose-dependent manner against HT29 and Caco-2 cells and influenced cell cycle kinetics.

Conclusions: In the colon p-cresol may reach physiologically significant concentrations which contribute to genotoxic exposures in the intestinal lumen, p-cresol production may be attenuated by substrate, and therefore diet, making it a potential modifiable biomarker of genotoxicity in the colon.     

Transthyretin stabilization activity of the catechol-O-methyltransferase inhibitor tolcapone (SOM0226) in hereditary ATTR amyloidosis patients and asymptomatic carriers: proof-of-concept study#

Objective: To assess the transthyretin (TTR) stabilization activity of tolcapone (SOM0226) in patients with hereditary ATTR amyloidosis, asymptomatic carriers and healthy volunteers.

Methods: A phase IIa proof-of-concept trial included two phases separated by a 6-week washout period. Phase A: single 200?mg dose of tolcapone; phase B: three 100?mg doses taken at 4?h intervals. The primary efficacy variable was TTR stabilization.

Results: Seventeen subjects were included (wild type, n?=?6; mutation TTR Val30Met, n?=?11). TTR stabilization was observed in all participants. Two hours after dosing, 82% of participants in phase A and 93% of those in phase B reached a TTR stabilization value of at least 20%. In phase A, there was an increase of 52% in TTR stabilization vs baseline values 2?h after dosing, which decreased to 22.9% at 8?h. In phase B, there was a significant increase of 38.8% in TTR stabilization 2?h after the first 100?mg dose. This difference was maintained after 10?h and decreased after 24?h. No serious adverse events were observed.

Conclusions: The ability of tolcapone for stabilizing TTR supports further development and repositioning of the drug for the treatment of ATTR amyloidosis.

EudraCT trial number: 2014-001586-27

ClinicalTrials.gov Identifier: NCT02191826     

Genetic and flow cytometry analysis of seronegative celiac disease: a cohort study

Background: Seronegative celiac disease (CD) poses a diagnostic challenge.

Aims: Characterize and identify differences between seronegative and seropositive CD.

Patients and methods: Retrospective cohort study examining adult patients diagnosed with CD (1980–2017). Clinical, analytical, histological, genetic and immunophenotypic data were compiled. Seronegative CD was defined as a anti-tissue transglutaminase type 2 IgA and endomysial antibodies (EMA) negative and HLA-DQ2 and/or DQ8 positive, showing clinical signs of CD plus an abnormal duodenal biopsy, and responding to a gluten-free diet (GFD). Factors associated with seronegative CD were identified through binomial logistic regression.

Results: Of 315?CD patients, 289 were seropositive (91.7%) and 26 seronegative (8.3%). Among the seronegative patients, higher prevalence was observed for autoimmune thyroiditis (26.9% vs. 9.7%, p?=?.016), HLA-DQ8 heterozygosity (23.1% vs. 2.5%, p???.001) and Marsh I lesion (34.6% vs. 3.7%, p???.001). The two groups showed similar flow cytometry-determined duodenal immunophenotypes and rates of refractory CD.

Conclusions: Seronegative CD differs mostly in genetic (more HLA-DQ8) and histologic (milder atrophy) features as compared with seropositive. Intestinal intraepithelial immunophenotype by flow cytometry, similar in both modalities, is a useful tool to diagnose seronegative CD.     

Cognitive Self-Efficacy and Mental Health Ratings after a Memory Skills Group for Older Veterans with PTSD

Objectives: Mental health factors, such as PTSD, can exacerbate typical age-related cognitive changes and lead individuals to have subjective concerns for which few interventions presently exist. This study evaluates self-reported mental health outcomes following a psychoeducational memory skills program designed for veterans over 50 with subjective memory concerns in the context of PTSD. It was hypothesized that outcomes would improve following program participation and that baseline cognitive self-efficacy would moderate improvements in self-reported depression and life satisfaction.

Methods: Veterans (n = 101, age ≥ 51) participated in an 8-week memory skills program and completed baseline and post-program assessment data as part of a quality improvement project.

Results: Life satisfaction and cognitive self-efficacy demonstrated significant improvement following participation in the memory skills program. Cognitive self-efficacy was found to significantly modify change in depressive symptoms.

Conclusions: We found improvement in mental health outcomes following participation in a psychoeducational memory skills program, with differential impact on depressive symptoms for those with low baseline cognitive self-efficacy.

Clinical Implications: Participation in this intervention led to improved life satisfaction and cognitive self-efficacy. Cognitive self-efficacy, in turn, appeared to have implications for improving depressive symptomology and may be a useful target of memory skills education.     

Clinical pertinence of neutrophil-to- lymphocyte ratio among hypertensives with different grades and duration of hypertension – an insight

Over the recent years, the pathophysiology of the inflammatory component in hypertension has been a challenge, because this inflammatory response is mainly contributed by an increased oxidative stress with the release of inflammatory mediators. Identification of a simple and early inflammatory marker such as the neutrophil-to-lymphocyte ratio (NLR) is the need of the hour. This study correlates the same specifically taking into account the duration and the grades of hypertension.

Objective: The response of the NLR among the hypertensives and its correlation with duration and stages of hypertension.

Method: Totally, 80 subjects and 40 controls of age between 20 and 60 years and both genders were included. Three recordings of blood pressure were measured with a standard mercury sphygmomanometer. The differential leukocyte count was estimated with an automated Beckman Coulter.

Objective: Variations in the neutrophil and lymphocyte counts were significant among the hypertensives with a p-value < 0.001. The NLR was also significantly altered among the hypertensives with a p-value = 0.001. The NLR showed a rise in value among the normotensives, prehypertensives, and stage 1 of systolic hypertension, though not statistically significant. An increase in the NLR was observed in hypertensives with duration of 1–2 years.

Conclusion: Our study gives a new insight with a rise in NLR in early years and even among prehypertensives and stage 1 systolic hypertension under strict criterion. This could be utilized as an early predictive tool, relating the inflammatory process and hypertension which on further intervention could slow the progression of the disease process.

Abbreviations: NLR: Neutrophil-to-lymphocyte ratio; BP: Blood pressure.     

Telephone-Delivered Cognitive Behavioural Therapy for Treating Symptoms of Anxiety and Depression in Parkinson’s Disease: A Pilot Trial

Objectives: To determine the feasibility, acceptability and initial efficacy of telephone-delivered cognitive behavioral therapy (CBT) for the treatment of anxiety and depressive symptoms in people with Parkinson’s disease.

Methods: A small randomized controlled trial compared telephone-based CBT to waitlist control. Eleven participants aged >50 years with Parkinson’s disease and anxiety and/or depressive symptoms above recommended clinical cut-offs, were randomized to one of two conditions. Participants completed self-report measures of symptom severity and quality of life. Their carers were invited to participate and completed self-reported measures of symptoms and carer burden. At the end of the 10-week intervention period, participants and carers were reassessed on baseline measures, and again one month later.

Results: The CBT program was associated with significantly reduced depressive symptoms (Cohen’s d = .90) at post-treatment with gains maintained at one-month follow-up. Anxiety symptom decreases (Cohen’s d = 0.36) were not statistically different. Waitlist was associated with significantly worsened anxiety. Carer symptoms also reduced with CBT. No changes on quality of life were found. Good acceptability and feedback was received.

Conclusions: Telephone-based CBT reduced symptoms of depression in participants with Parkinson’s disease but not anxiety.

Clinical Implications: Telephone-based CBT is a promising treatment option.     

Intracellular concentration and transporters in imatinib resistance of gastrointestinal stromal tumor

Background: We aimed to investigate the role of intracellular imatinib concentration in drug resistance and the expression of candidate drug transporters in gastrointestinal stromal tumor (GIST) cell lines.

Method: The imatinib concentrations were measured by the liquid chromatography-tandem mass spectrometry (LC-MS/MS). The expression of candida te drug transporters was detected by qRT-PCR.

Results: The tissue imatinib concentrations in imatinib resistant patients were significantly lower than that of sensitive patients (p?<?.05). Compared with parental cell lines, the intracellular imatinib concentration was notably lower in imatinib resistant GIST cell lines. For candidate transporters, MRP1 and BCRP were overexpressed in resistant GIST cell lines.

Conclusion: The intracellular imatinib concentration may play a crucial role in imatinib resistance and the intracellular differences of imatinib concentration may be induced by the upregulation of efflux transporters. Our study highlights the importance of intracellular imatinib concentration and the potential of using imatinib transporters as therapeutic targets for patients with GIST.     

Increased Reporting of Exclusionary Diagnoses Inflate Apparent Reductions in Long-Stay Antipsychotic Prescribing

Objective: Over the two years following the 2012 introduction of CMS’s National Partnership, combined rates of schizophrenia, Tourette’s, and Huntington’s in US long-stay residents increased 12%. We evaluated trends in reporting of these diagnoses for the subgroup of long-stay residents on antipsychotics.

Methods: Retrospective analysis of Virginia Medicaid claims identified annual utilization rates of psychiatric diagnoses for long-stay seniors on antipsychotics. Chi-square analysis compared rates for the year before March, 2012 with the same 12-month period 1 year later. A 5-year pre-existing baseline rate was also obtained.

Results: Diagnosis rates for 2011 were unchanged from baseline. Comparing 2011 with 2013, diagnoses rates for schizophrenia, Tourette’s, and Huntington’s combined increased 40% (p < .0001), primarily because schizophrenia reporting nearly doubled (p < .0001).

Conclusions: For long-stay seniors on antipsychotics, reporting of schizophrenia, Tourette’s, and Huntington’s began increasing in 2012 and at almost triple the rate CMS described for the general long-stay population. The increased reporting of these diagnoses described by CMS since 2012 appears to be new and concentrated in residents on antipsychotics

Clinical Implications: Since antipsychotics prescribed for schizophrenia, Tourette’s, and Huntington’s are excluded from quality-measure auditing, apparent reductions in inappropriate long-stay antipsychotic use since the National Partnership may be exaggerated.     

Evaluation of fatigue in inflammatory bowel disease - a useful tool in daily practice

Background: Fatigue is a common symptom reported in inflammatory bowel disease (IBD) patients. It can be severe and modify the self-perception of disease.

Objective: To evaluate the contribution of clinical and demographic factors to the level of fatigue in IBD patients.

Methods: Patients consecutively observed in an outpatient IBD clinic during a 9-month period were studied. Demographic and clinical data were collected. Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). A FACIT-F score <30 was considered as severe fatigue.

Results: One hundred and five patients were evaluated. Of them, 57.1% had Crohn´s Disease (CD) and 42.9% had Ulcerative Colitis. Also 85.0% and 77.8% were in clinical remission, respectively. The mean FACIT-F score was 39.63?±?9.67. Severe fatigue was observed in 17.1% of patients. Female gender and active CD were significantly associated with a severe level of fatigue (p?=?.05 and p?=?.04). There was no significant correlation between the level of fatigue (severe vs. non-severe) and type of IBD, hemoglobin, C-reactive protein, ferritin levels or previous surgeries. Patients under biological therapy had a significantly higher level of fatigue and a higher rate of previous hospitalizations (p?=?.02).

Conclusions: Fatigue level is a simple and useful tool to evaluate the disease’s impact in patients’ life, and it should, therefore, be included in clinical practice. Biological therapy was associated to higher levels of fatigue. Future studies should evaluate the impact of therapy on the level of fatigue.     

Providing Assistance for Older Adult Financial Exploitation Victims: Implications for Clinical Gerontologists

Background and Objective: Despite the growth of financial exploitation research in the past decade, almost none has focused on older urban adults, and especially urban African Americans. The Success After Financial Exploitation (SAFE) program provides individual financial coaching to older urban adults.

Methods: We use community education, delivered separately to older adults and to the professionals who serve them, to raise awareness about financial exploitation (FE) and to motivate referrals for financial coaching. This paper describes the program and methodology, and uses case examples and preliminary research to investigate the intersection of FE and physical and mental health functioning.

Results: SAFE participants were able to repair their credit scores, reduce new financial burdens, and even recover monies they had lost due to FE. Case examples illustrate how financial scams and identity theft impacts urban older adults. Participants were assessed prior to the provision of services, and SAFE participants performed poorer on executive functioning tasks than participants in the control group. They also reported more physical health problems and anxiety and depressive symptoms. SAFE participants also had significantly higher risk scores on a financial decision-making scale.

Conclusion: Study findings advance our understanding of the impacts of FE on cognitive functioning, mental health, and financial decision-making.

Clinical Implications: Clinicians need to be more attuned to the financial health of their older clients, who, if they are struggling with financial exploitation, may also be suffering from problems with cognitive functioning and physical and mental health.     

Using a Reminiscence-based Approach to Investigate the Cognitive Reserve of a Healthy Aging Population

Objectives: The concept of Cognitive Reserve (CR) has been used to account for brain plasticity in older adults that may underlie the resilience against the effects of aging or pathology on cognitive abilities. This study aims at exploring the proxies of CR in a sample of healthy older adults by analyzing their spontaneous reminiscence through a discourse analysis approach.

Method: Fifteen community-dwelling older adults were asked to participate in a video-recorded, spontaneous reminiscence interview. Interviews were transcribed according to Conversation Analysis, and two judges classified the interview content identifying five main markers of CR: enriched environment, cognitively stimulating activities, education, physical activity, and social interaction.

Results: Reminiscence allowed to identify markers of CR. Sharing stories that are linked to CR markers promote positive emotion, coherent sense of self, and cognitive evaluation of the importance of the social network.

Conclusions: Reminisce looks like a possible approach not only to indirect evaluate the CR, but also to promote it.

Clinical Implications: The reminisce approach can be used as a clinical tool to assess and increase the CR, help the clinical population to experience more positive emotions, maintain a more defined sense of self, and value more the social resources available.     

Self-Compassion,Coping Strategies,and Caregiver Burden in Caregivers of People with Dementia

Objective: Caring for someone with dementia can have negative consequences for caregivers, a phenomenon known as caregiver burden. Coping strategies influence the impact of caregiving-related stress. Specifically, using emotion-focused strategies has been associated with lower levels of burden, whereas dysfunctional strategies have been related to increased burden. The concept of self-compassion has been linked to both positive outcomes and the coping strategies that are most advantageous to caregivers. However, as yet, no research has studied self-compassion in caregivers. Therefore, the aim of this study was to explore the relationship between self-compassion, coping strategies and caregiver burden in dementia caregivers.

Method: Cross-sectional survey data was collected from 73 informal caregivers of people with dementia recruited from post-diagnostic support services and caregiver support groups.

Results: Self-compassion was found to be negatively related to caregiver burden and dysfunctional coping strategies and positively related to emotion-focused coping strategies. Dysfunctional strategies mediated the relationship between self-compassion and caregiver burden, whereas emotion-focused strategies did not.

Conclusion: Caregivers with higher levels of self-compassion report lower levels of burden and this is at least partly due to the use of less dysfunctional coping strategies.

Clinical Implications: Interventions that develop self-compassion could represent a useful intervention for struggling caregivers.     

Adalimumab in the treatment of chronic pouchitis. A randomized double-blind,placebo-controlled trial

Background: Pouchitis is a complication of ileal pouch-anal anastomosis and occurs in up to 50% of patients 10 years after IPAA with 10% developing refractory pouchitis.

Objective: To evaluate the effect of a TNF-α inhibitor (Adalimumab) in the treatment of refractory pouchitis.

Materials and methods: A multicenter, randomized double-blind, placebo-controlled trial includes patients with refractory pouchitis for more than 4 weeks despite antibiotic treatment. Patients were randomized to Adalimumab or placebo for 12 weeks. Primary outcome was reduction in clinical pouchitis disease activity index (PDAI) of ≥2 at any time. Secondary endpoints were remission of pouchitis, endoscopic and histologic effect and quality of life.

Results: Thirteen patients were included; six patients received active treatment and seven patients received placebo. Nine patients (5/4, Adalimumab/placebo) completed the 12-week program. Reduction in clinical PDAI ≥ 2 was achieved in three patients in each group (50%/43%, Adalimumab/placebo, p?>?.5). Total PDAI improved in six patients treated with Adalimumab and two patients on placebo (100%/29%, p?=?.13). There were no differences in secondary endpoints between the groups.

Conclusions: In this randomized controlled trial of treatment with Adalimumab in patients with refractory pouchitis, we were not able to identify any clinical benefit in the primary or secondary endpoints.