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

Study Overview
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Brief Summary
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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: change of VAS score for abdominal pain/discomfort after 4/8-week treatment daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: GI Flora
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GI Flora<br>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)% | Dietary Supplement: GI Flora<br> <br> |
| Placebo Comparator: placebo<br>Dextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)% | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for abdominal pain |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI Flora