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

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 Overview

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 1425
        • Cemic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice
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.
Probiotic yeast in capsules
Other Names:
  • 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
ACTIVE_COMPARATOR: Dietary advice without medication
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale
Time Frame: 15 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hydrogen excretion measured by lactulose breath test
Time Frame: 15 days

Presence of bacterial overgrowth was examined by a lactulose hydrogen breath test (LHBT), which measures hydrogen concentration within the expelled breath.

Patients ingested 10 mL lactulose, then breath samples were collected every 20 minutes over 180 min and analyzed to determine hydrogen concentration. An excreted hydrogen concentration/time area under the curve (AUC) was then calculated. A positive test corresponded to any of the following results: rise in breath hydrogen at least 20 ppm above basal levels within 100 minutes after ingestion of lactulose; rise at least 12 ppm within100 minutes with a decrease of 5 ppm (markers of SIBO) and subsequent increase; (AUC) value of more than 3000 ppm. Changes in terms of absolute hydrogen excretion measured by AUC of hydrogen excretion over time were compared before and after intervention in every patient.

15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

August 31, 2018

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

November 7, 2020

First Posted (ACTUAL)

November 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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