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

• ClinicalTrials.gov Identifier: NCT04627337
• Recruitment Status: Completed
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Information provided by (Responsible Party): Juan Lasa, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Tracking Information

• First Submitted Date: November 28, 2018
• First Posted Date: November 13, 2020
• Last Update Posted Date: November 13, 2020
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: July 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 7, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Irritable Bowel Syndrome

Intervention

• Drug: Saccharomyces Boulardii 250 MG
  Probiotic yeast in capsules
  Other Name: 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

Study Arms

• 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.
  Interventions:

  • Drug: Saccharomyces Boulardii 250 MG
  • Behavioral: Dietary advice following a low fermentation diet
• 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.
  Intervention: Behavioral: Dietary advice following a low fermentation diet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 7, 2020): 71
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 31, 2018
• Actual Primary Completion Date: July 30, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina

Administrative Information

• NCT Number: NCT04627337
• Other Study ID Numbers: CEIBO01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Juan Lasa, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Original Responsible Party: Same as current
• Current Study Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Verification Date: November 2020