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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05149599
Other study ID # 2731020MSGE
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date October 31, 2021

Study information

Verified date December 2022
Source Ziauddin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Dr. Ziauddin University Hospital Clifton Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Ziauddin University Hilton Pharma

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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