NCT05451433

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

June 22, 2022

Last Update Submit

July 18, 2022

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Saccharomyces Boulardii 250 MGDRUG

Normagut capsule twice a day

Also known as: Normagut
Intervention Group
PlaceboDRUG

Placebo capsule twice a day

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • diagnosed with IBS based on ROME IV criteria
  • agree to be participant by signing inform consent

You may not qualify if:

  • patient who does not want to sign the inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blind randomized control trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 11, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL