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Completed

NCT Number: NCT05149599

Saccharomyces Cerevisiae for Irritable Bowel Syndrome

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dr. Ziauddin University Hospital Clifton

Karachi, Sindh, 75600, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saccharomyces cerevisiae

Drug

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

Primary outcomes

  1. To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with Irritablebowel syndrome through pain/ discomfort score

    Time frame: One month

    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 outcomes

  1. To determine the response of saccharomyces cerevisiae for symptomatic improvement in patients with IBS through IBS quality of life questionnaire

    Time frame: One month

    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.

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Collaborators

  • Hilton Pharma

Registry information

Official study title

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

Acronym: IBS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2021
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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