Effcacy of Probiotic Escherichia coli Nissle 1917 in Patients with Irritable Bowel Syndrome: a Double Blind Placebocontrolled Randomized Trial

ABSTRACT: to evaluate potential improvement effect for probiotic E. coliNissle 1917 in the management of refractory IBS in an Iranian population. Methods: a double blind placebo controlled approach has been used in the current clinical trial. 139 confrmed IBS patients were included into the study, and were given probiotic E.coli Nissle 1917 for 6 weeks. 11 items Birmingham IBS Symptom Questionnairehas been used for evaluation of changes in the symptoms every 2 weeks. Results: sixty eight subjects (49%) were males. Mean±SD age of the participants was 38±13.3 years. 49(35.3%) of the patients were diarrhea-predominant. The total scores showed no signifcant difference between the intervention vs. control group(-6.7±6.8 vs. -6.7±6.5, respectively; p=0.95); neither did any of the questionnaire items any signifcant alterations in the two groups. After stratifcation of patients based on their IBS type, diarrhea-predominant patients showed a positive response to the probiotic improving their sleep (p=0.05&0.03 at weeks 2&6, respectively). Patients with constipation-predominant IBS showed no response to the probiotic; while patients with diarrhea-constipation mixed IBS showed unfavorable response to the probiotic in the need for strain to pass a motion compared to the placebo (p=0.03&0.02 at weeks 4&6, respectively). Conclusion: probiotic therapy with E.coliNissle 1917 was not able to induce signifcant improvement in the symptoms of patients with non-categorized IBS. Nevertheless, when IBS patients were recategorized to subgroups according to their main symptoms, evaluation of the effcacy of the probiotic on some individual items in the symptom list reached the signifcance level. Prospective clinical trials are recommended to confrm our fndings.
Key words: probiotic Escherichia Coli Nissle 1917, irritable bowel syndrome, double blind randomized controlled trial
Author: Amir H. Faghihi, Shahram Agah, Mohsen Masoudi, Seyed M.S. Ghafoori, Abbas Eshraghi
Journal Code: jpkedokterangg150246