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
