Saccharomyces Cerevisiae for Irritable Bowel Syndrome

Phase 2CompletedNCT05149599

Ziauddin University30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

Saccharomyces cerevisiaeDRUG

Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dr. Ziauddin University Hospital Clifton

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

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

Time frame: One month

Secondary Outcomes

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.

Time frame: One month

Data from ClinicalTrials.gov

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