Irritable Bowel Syndrome
Conditions
Keywords
GI Flora
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
Interventions
DIETARY_SUPPLEMENTGI Flora
DIETARY_SUPPLEMENTPlacebo
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale for abdominal pain | 8 weeks |
Outcome results
None listed