A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Analogue Scale for abdominal pain 8 weeks
- Secondary Outcome Measures
Name Time Method
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