Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Drug: Saccharomyces Boulardii 250 MGBehavioral: Dietary advice following a low fermentation diet
- Registration Number
- NCT04627337
- Lead Sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- Adult patients
- Diagnosis of Irritable Bowel syndrome according to Rome III criteria
- Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test
- Pregnancy
- Diagnosis of Celiac disease
- Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
- Immunosuppression
- Diagnosis of active cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice Saccharomyces Boulardii 250 MG 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. Saccharomyces boulardii (1 capsule of 250 ug BID) + Dietary advice Dietary advice following a low fermentation diet 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 Dietary advice following a low fermentation diet 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.
- Primary Outcome Measures
Name Time Method Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale 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.
- Secondary Outcome Measures
Name Time Method Change in hydrogen excretion measured by lactulose breath test 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.
Trial Locations
- Locations (1)
CEMIC
🇦🇷Buenos Aires, Argentina