Diarrhea Predominant Irritable Bowel Syndrome | The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
Diarrhea Predominant Irritable Bowel Syndrome research study
What is the primary objective of this study?
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.
Who is eligible to participate?
Inclusion Criteria: - willing to consent/undergo necessary procedures - between the age of 19 and 75 years - diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria) Exclusion Criteria: - uncontrolled hypertension (Blood pressure > 180/110 mmHg) - uncontrolled diabetes mellitus (FBS > 200 mg/dL) - malignancy, cerebrovascular disease, cardiovascular disease - history of abdominal surgery except appendectomy and hernia repair - inflammatory bowel disease - clinically or laboratory-confirmed gastroenteritis - the use of motility drug or dietary fiber supplement in 2 weeks - serum Cr > 2 x Upper normal limit - AST or ALT > 2 x Upper normal limit - Pregnancy, Lactating woman
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Diarrhea Predominant Irritable Bowel Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Multi-strain probioticsB. longum BORI: 1 x 109 B. bifidum BGN4: 1 x 109 B. lactis AD011: 1 x 109 B. infantis IBS007: 1 x 109 Lactobacillus acidophilus AD031: 1 x 109 three times a day, within 10 minutes after meal, per oral with water
Drug:Placebo powdersame taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2012
Completed Date: July 2013
Primary Outcome: change of Irritable bowel syndrome symptom severity score (IBS-SSS)
Secondary Outcome: Stool frequency and form
Study sponsors, principal investigator, and references
Principal Investigator: Joo Sung Kim, M.D.,PhD
Lead Sponsor: Seoul National University Hospital