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

Seoul National University

Status: Unknown

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: GI Flora; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02419027

CBT-GS14

Details and patient eligibility

About

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

Enrollment: 116 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups, including a placebo group

GI Flora

Experimental group

Description:

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)%

Treatment:

Dietary Supplement: GI Flora

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo