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

Primary Purpose

Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saccharomyces Boulardii 250 MG
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Get intervention drug Normagut capsule twice a day

    Get placebo capsule twice a day

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 22, 2022
    Last Updated
    July 18, 2022
    Sponsor
    Fakultas Kedokteran Universitas Indonesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05451433
    Brief Title
    The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS
    Official Title
    The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fakultas Kedokteran Universitas Indonesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Double blind randomized control trial
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Get intervention drug Normagut capsule twice a day
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Get placebo capsule twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Saccharomyces Boulardii 250 MG
    Other Intervention Name(s)
    Normagut
    Intervention Description
    Normagut capsule twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo capsule twice a day
    Primary Outcome Measure Information:
    Title
    Clinical improvement quality of life within 29 days
    Description
    Measuring quality of life using questionnaire IBS-QOL from 0-100, the higher the score, the better the outcome.
    Time Frame
    29 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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