Suspended

A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome

What is being tested

GI Flora

+ Placebo

Dietary Supplement

Who is being recruted

Colonic Diseases+3

+ Colonic Diseases, Functional

+ Digestive System Diseases

From 19 to 70 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: May 2015

See protocol details

Summary

Principal SponsorSeoul National University Hospital

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2015

Actual date on which the first participant was enrolled.

A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel Syndrome. Regimen: 6 probiotics mixture >10\^9/D for 8 weeks Primary variable: visual analogue scale(VAS) assessment for abdominal pain Secondary variable: 1. change of VAS score for abdominal pain/discomfort after 4/8-week treatment 2. daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements

Official TitleA Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome

NCT02419027

Principal SponsorSeoul National University Hospital

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesIrritable Bowel Syndrome

Criteria

2 inclusion criteria required to participate

Irritable bowel syndrome patients according to Rome III criteria

Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.

5 exclusion criteria prevent from participating

Intolerable or hypersensitive to GI Flora.

Patients with active colon diverticulitis.

History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation.

History of inflammatory bowel disease, malignancy requiring surgery or chemotherapy or radiation within 5 years.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Lactobacillus acidophilus LA1 1.312% Lactobacillus rhamnosus LR5 0.656% Lactobacillus paracasei LPC5 0.656% Bifidobacterium lactis BL3 1.312% Bifidobacterium breve BR3 1.312% Pediococcus pentosaceus SL4 1.312% Prolac-T(heat-killed L. acidophilus LA1) 24.286% Dextrose 60.000% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%

Group II

Placebo

Dextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers