Saccharomyces Cerevisiae for Irritable Bowel Syndrome (IBS)

Ziauddin University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Saccharomyces cerevisiae

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05149599

2731020MSGE

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treated patients

Experimental group

Treatment:

Drug: Saccharomyces cerevisiae