Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth

NCT04627337 | Completed Phase 4 DMC

• 1 other identifier: CEIBO01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale

  The IBS Symptom Severity Scale (IBS-SSS) is a validated questionnaire (Francis et al. 1997) that evaluates the intensity of the following IBS symptoms: abdominal pain, distension, stool frequency and consistency, and general impact on life. The IBS-SSS calculates the sum of these 5 items (each scored on a visual analogue scale from 0 to 100) and the score values range from 0 to 500 (maximum severity). An IBS-SSS questionnaire was filled-in by each randomized patient at both visits. We compared the difference between the overall score before and after the intervention.

  15 days

Secondary Outcomes (1)

• Change in hydrogen excretion measured by lactulose breath test

  15 days

Study Arms (2)

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.

Drug: Saccharomyces Boulardii 250 MG; Behavioral: Dietary advice following a low fermentation diet

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.

Behavioral: Dietary advice following a low fermentation diet

Interventions

Saccharomyces Boulardii 250 MG DRUG

Probiotic yeast in capsules

Also known as: Dietary advice following a low fermentation diet

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

Dietary advice following a low fermentation diet BEHAVIORAL

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

Dietary advice without medication; Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Diagnosis of Celiac disease
• Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
• Immunosuppression
• Diagnosis of active cancer

Sponsors & Collaborators

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: lead

Study Sites (1)

CEMIC

Buenos Aires, 1425, Argentina

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 13, 2020
• Study Start: February 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 31, 2018
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)