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

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: GI Flora; Dietary Supplement: Placebo

• Registration Number: NCT02419027
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-16
• Last Update Submitted: 2015-04-16
• Study First Posted: 2015-04-17
• Last Update Posted: 2015-04-17
• Study Start: 2015-05
• Primary Completion: 2016-05
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GI Flora	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)%
placebo	Placebo	Dextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for abdominal pain	8 weeks