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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627337
• Other study ID #: CEIBO01
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2020
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 31, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Saccharomyces Boulardii 250 MG
Probiotic yeast in capsules

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

Locations

Country	Name	City	State
Argentina	CEMIC	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in hydrogen excretion measured by lactulose breath test	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