Saccharomyces Cerevisiae for Irritable Bowel Syndrome
IBS
Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedFirst Submitted
Initial submission to the registry
November 24, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedDecember 7, 2022
December 1, 2022
8 months
November 24, 2021
December 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire
One month
Study Arms (1)
Treated patients
EXPERIMENTALInterventions
Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month
Eligibility Criteria
You may qualify if:
- 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),
- Not hypersensitive to any of the ingredients of the drug.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziauddin Universitylead
- Hilton Pharmacollaborator
Study Sites (1)
Dr. Ziauddin University Hospital Clifton
Karachi, Sindh, 75600, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mehreen Siyal, MBBS, FCPS-1
DR ZIAUDDIN HOSPITAL, CLIFTON CAMPUS
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Gastroenterology
Study Record Dates
First Submitted
November 24, 2021
First Posted
December 8, 2021
Study Start
March 1, 2021
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
December 7, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share