The Effect of Saccharomyces Boulardii in Clinical Present... | NCT05451433

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

NCT05451433

Sponsor

Fakultas Kedokteran Universitas Indonesia

Status

Unknown status

Last Update Posted

Jul 20, 2022Actual

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome

Interventions

Saccharomyces Boulardii 250 MG
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Estimated

Primary Completion Date

Aug 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jun 22, 2022

First Submission Date that Met QC Criteria

Jul 5, 2022

First Posted Date

Jul 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2022

Last Update Posted Date

Jul 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Professor, Fakultas Kedokteran Universitas IndonesiaPrincipal Investigator

Lead Sponsor

Fakultas Kedokteran Universitas IndonesiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	Get intervention drug Normagut capsule twice a day	Drug: Saccharomyces Boulardii 250 MG
Control Group	Placebo Comparator	Get placebo capsule twice a day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saccharomyces Boulardii 250 MG	Drug	Normagut capsule twice a day	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided