A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome.

BACKGROUND: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms. METHODS: In this double-blind trial 400 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic Bio-Kult® (14 different bacterial strains) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure. RESULTS: Probiotic treatment significantly improved the severity of abdominal pain in patients with IBS-D. A 69% reduction for probiotic versus 47% for placebo (p < 0.001) equates to a 145 point reduction on the IBS-severity scoring system (IBS-SSS). The proportion of patients who rated their symptoms as moderate-to-severe was reduced from 100% at baseline to 14% for the multi-strain probiotic at follow-up (month 5) versus 48% for placebo (p < 0.001). Also, the number of bowel motions per day from month 2 onwards was significantly reduced in the probiotic group compared with the placebo group (p < 0.05). In addition to relieving symptoms, the probiotic markedly improved all dimensions of quality of life in the 34-item IBS-Quality of Life (IBS-QoL) questionnaire. No serious adverse events were reported. CONCLUSIONS: The multi-strain probiotic was associated with significant improvement in symptoms in patients with IBS-D and was well-tolerated. These results suggest that probiotics confer a benefit in IBS-D patients which deserves further investigation. TRIAL REGISTRATION: [Clinicaltrials.gov NCT03251625 ; retrospectively registered on August 9, 2017].

Long-term re-infection rate after Helicobacter pylori eradication in Bangladeshi adults.

BACKGROUND AND AIM: Bangladesh is a developing country with a very high prevalence of Helicobacter pylori infection, which has been ascribed to overcrowding and poor sanitary conditions. It has generally been accepted that the re-infection rate is higher in countries with a high prevalence of H. pylori infection. Short-term follow-up studies support this assumption but no long-term studies are available to confirm or refute this assertion. The present study was aimed to define the long-term H. pylori re-infection rate (6 years after successful eradication) in duodenal ulcer patients. METHODS: In a previous study, 90 patients were successfully eradicated for H. pylori and followed-up for 24 months. 17/90 were found to be re-infected (18% re-infection rate per year in the first 12 months) [Gastroenterology 2001;792-798]. The remaining 73 patients were targeted for long-term follow-up. 26/73 were lost to follow-up; 6 symptomatic patients were tested H. pylori positive in the period between 24 and 60 months post-eradication. The remaining 41 patients were evaluated 72 months after successful eradication. The evaluation included clinical history taking, a (13)C-urea breath test (UBT), and endoscopy. RESULTS: Of the 41 H. pylori-eradicated patients analyzed after 72 months, 16 were H. pylori-positive. If the 6 patients, who were tested positive between 24 and 60 months, are added, the total re-infection cases amount to 22 subjects in the period between 24 and 72 months. Therefore, an overall annual re-infection rate 6 years after eradication of 5.02% can be calculated. Six of the 23 symptomatic patients had duodenal ulcer relapse, 5/6 were H. pylori re-infected and one was H. pylori-negative at 72 months post-treatment. CONCLUSION: The long-term annual H. pylori re-infection rate in Bangladeshi adults is markedly higher than in Western countries but lower than anticipated. In this study, duodenal ulcer relapse is clearly related to H. pylori re-infection.