Saccharomyces Cerevisiae for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS

Official Title
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Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Saccharomyces cerevisiae


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients between 18 and 75 years of age, Patients having confirmed IBS according to Rome IV criteria (newly and previously non-responder to treatment), Pain/ discomfort score strictly above 1 and strictly below 6 as determined on a pain/ discomfort scale using arbitrary grading from 0 to 7 in 7 days preceding the inclusion visit, Not hypersensitive to any of the ingredients of the drug. Exclusion Criteria: Patients with an organic intestinal disease (Crohn's disease, ulcerative colitis, etc.), Pregnant females Treatments likely to influence IBS (anti-depressants, opioids, and narcotic analgesics) Patients with chronic alcoholism, vegetarian or vegan regimens Eating disorders such as anorexia or bulimia Documented food allergies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated patients<br> | Drug: Saccharomyces cerevisiae<br>* Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score | Responders were defined as the patients who had an improvement of 50% of the weekly average intestinal pain/discomfort score compared with the baseline average score for at least 2 out of the 4 weeks of study duration | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire | The IBS-QOL was evaluated using a validated 34-item IBS-QOL questionnaire, with each item scored on a 5-point Likert response scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = quite a bit, and 5 = 'extremely' or 'a great deal'). The individual responses to the 34 items of the IBS-QOL questionnaire were summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation, with higher scores indicating better IBS specific quality of life. | One month |