Saccharomyces Cerevisiae for Irritable Bowel Syndrome

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Saccharomyces cerevisiae

• Registration Number: NCT05149599
• Lead Sponsor: Ziauddin University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated patients	Saccharomyces cerevisiae	-

Primary Outcome Measures

Name	Time	Method
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score	One month	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

Secondary Outcome Measures

Name	Time	Method
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire	One month	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.

Trial Locations

Locations (1)

Dr. Ziauddin University Hospital Clifton; 🇵🇰 Karachi, Sindh, Pakistan