Saccharomyces Cerevisiae for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— IBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05149599
• Other study ID #: 2731020MSGE
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

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