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

July 18, 2022 updated by: Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Fakultas Kedokteran Universitas Indonesia
This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Get intervention drug Normagut capsule twice a day
Drug: Saccharomyces Boulardii 250 MG
Normagut capsule twice a day
Other Names:
  • Normagut
Placebo Comparator: Control Group
Get placebo capsule twice a day
Drug: Placebo
Placebo capsule twice a day

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-03-0280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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