Trial | NCT04627337  Report issue

Title

Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth
Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in the Treatment of Small Intestinal Bacterial Overgrowth in Patients Suffering From Irritable Bowel Syndrome With Diarrhea

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    71
Non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. Saccharomyces boulardii CNCM I-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. However, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. Hence, an exploratory randomized, open label trial comparing the efficacy and safety of Saccharomyes boulardii CNCM I-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.
Study Started
Feb 01
2017
Primary Completion
Jul 30
2018
Study Completion
Aug 31
2018
Last Update
Nov 13
2020

Drug Saccharomyces Boulardii 250 MG

Probiotic yeast in capsules

  • Other names: Dietary advice following a low fermentation diet

Behavioral Dietary advice following a low fermentation diet

Medical advice was delivered to patients to follow a low fermentation diet. A list of food and beverages to avoid was delivered along with specified instructions provided by a health professional

Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice Experimental

Patients received 1 capsule of Saccharomyces boulardii 250 ug BID plus dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.

Dietary advice without medication Active Comparator

Patients received dietary advice for 15 days. Dietary advice consisted of a low fermentation diet which was delivered as a written list of food and beverages that patients should avoid adapted to local habits and an oral explanation by a health professional.

Criteria 

Inclusion Criteria:

Adult patients
Diagnosis of Irritable Bowel syndrome according to Rome III criteria
Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test

Exclusion Criteria:

Pregnancy
Diagnosis of Celiac disease
Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
Immunosuppression
Diagnosis of active cancer
No Results Posted