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

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Saccharomyces Boulardii 250 MG; Drug: Placebo

• Registration Number: NCT05451433
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2022-06-22
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Study Start: 2022-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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Exclusion Criteria

• patient who does not want to sign the inform consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Saccharomyces Boulardii 250 MG	Get intervention drug Normagut capsule twice a day
Control Group	Placebo	Get placebo capsule twice a day

Primary Outcome Measures

Name	Time	Method
Clinical improvement quality of life within 29 days	29 days	Measuring quality of life using questionnaire IBS-QOL from 0-100, the higher the score, the better the outcome.