Irritable Bowel Syndrome
Conditions
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.
Interventions
Probiotic yeast in capsules
BEHAVIORALDietary 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
Sponsors
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina
Outcome results
None listed