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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

NCT04662957

Irritable Bowel Syndrome With Diarrhea Effects of Probiotics

COMPLETED NA

The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome

NCT01637714

Diarrhea Predominant Irritable Bowel Syndrome

UNKNOWN NA

Efficacy of a Probiotic Blend to Reduce Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome

NCT05819281

Irritable Bowel Syndrome

UNKNOWN PHASE2

Exploring the Mechanism of a Probiotic Combination VSL#3 in Irritable Bowel Syndrome

NCT00786123

Irritable Bowel Syndrome

COMPLETED NA

Probiotics in Irritable Bowel Syndrome

NCT00846170

Irritable Bowel Syndrome

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GI Flora

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 Type EXPERIMENTAL

GI Flora

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GI Flora

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No