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Saccharomyces Cerevisiae for Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Saccharomyces cerevisiae
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dr. Ziauddin University Hospital Clifton

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated patients

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 24, 2021
Last Updated
December 4, 2022
Sponsor
Ziauddin University
Collaborators
Hilton Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05149599
Brief Title
Saccharomyces Cerevisiae for Irritable Bowel Syndrome
Acronym
IBS
Official Title
Efficacy and Safety of Saccharomyces Cerevisiae for Abdominal Pain and Discomfort in Irritable Bowel Syndrome (IBS) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University
Collaborators
Hilton Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Saccharomyces cerevisiae
Intervention Description
Saccharomyces cerevisiae, which is a pro-biotic, was given in capsule form, 500mg twice daily for 1 month
Primary Outcome Measure Information:
Title
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score
Description
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
Time Frame
One month
Secondary Outcome Measure Information:
Title
To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire
Description
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.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehreen Siyal, MBBS, FCPS-1
Organizational Affiliation
DR ZIAUDDIN HOSPITAL, CLIFTON CAMPUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ziauddin University Hospital Clifton
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Saccharomyces Cerevisiae for Irritable Bowel Syndrome

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