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

NCT ID: NCT05451433

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-12-01

Brief Summary

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

Detailed Description

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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

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double blind randomized control trial

Study Groups

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Intervention Group

Get intervention drug Normagut capsule twice a day

Group Type EXPERIMENTAL

Saccharomyces Boulardii 250 MG

Intervention Type DRUG

Normagut capsule twice a day

Control Group

Get placebo capsule twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule twice a day

Interventions

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Saccharomyces Boulardii 250 MG

Normagut capsule twice a day

Intervention Type DRUG

Placebo

Placebo capsule twice a day

Intervention Type DRUG

Other Intervention Names

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Normagut

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Marcellus Simadibrata, Prof. PhD., SpPD, KGEH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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22-03-0280

Identifier Type: -

Identifier Source: org_study_id

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