Diarrhea Predominant Irritable Bowel Syndrome
Conditions
Brief summary
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.
Interventions
* B. 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
DRUGPlacebo powder
same taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Irritable bowel syndrome symptom severity score (IBS-SSS) | after 8 weeks | Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment for patient satisfaction after administration completion | after 4 weeks and 8 weeks | — |
| Stool frequency and form | after 4 weeks and 8 weeks | Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool) |
| Symptom control of irritable bowel syndrome | after 4 weeks and 8 weeks | — |
| Improvement of overall symptom in patient with irritable bowel syndrome | after 4 weeks and 8 weeks | — |
| Assessment for quality of life related with irritable bowel syndrome | after 4 weeks and 8 weeks | — |
Countries
South Korea
Contacts
Primary ContactJoo Sung Kim, M.D., PhD
Backup ContactKyoung Sup Hong, M.D.
Outcome results
None listed