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NCT05451433 Clinical Trial

The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS

Irritable Bowel Syndrome Clinical Trial

Official title:
The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05451433
Other study ID # 22-03-0280
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date December 1, 2022

Study information
Verified date July 2022
Source Fakultas Kedokteran Universitas Indonesia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome

Description:

This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome within timeframe of study 28 days and then will be examined the outcome as the improvement quality of life

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 52
Est. completion date December 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criterias: - 18 years or older - diagnosed with IBS based on ROME IV criteria - agree to be participant by signing inform consent Exclusion Criteria: - patient who does not want to sign the inform consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Saccharomyces Boulardii 250 MG
Normagut capsule twice a day
• Placebo
Placebo capsule twice a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fakultas Kedokteran Universitas Indonesia

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical improvement quality of life within 29 days Measuring quality of life using questionnaire IBS-QOL from 0-100, the higher the score, the better the outcome. 29 days
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