Diarrhea Predominant Irritable Bowel Syndrome
Conditions
Brief summary
The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.
Interventions
DIETARY_SUPPLEMENTSoy Dietary Fiber
Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL
DIETARY_SUPPLEMENTRice powder
Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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 \> 170/100 mmHg) * uncontrolled diabetes mellitus (FBS \> 180 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 * allergy to soy fiber * 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 |
|---|---|---|
| sum of irritable bowel syndrome symptom score | after 4 weeks | abdominal pain / abdominal discomfort urgency tenesmus abdominal distension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| irritable bowel syndrome symptom score | after 2 weeks and 4 weeks | abdominal pain / abdominal discomfort urgency tenesmus abdominal distension |
| Stool frequency and form | after 2 weeks and 4 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 2 weeks and 4 weeks | — |
| Improvement of overall symptom in patient with irritable bowel syndrome | after 2 weeks and 4 weeks | — |
| Severity of overall symptom in patient with irritable bowel syndrome | after 2 weeks and 4 weeks | — |
| Severity of diarrhea | after 2 weeks and 4 weeks | — |
| Assessment for quality of life related with irritable bowel syndrome | after 2 weeks and 4 weeks | — |
| Assessment for patient satisfaction after administration completion | after 2 weeks and 4 weeks | Overall satisfaction for treatment Whether the patient will keep up treatment |
Countries
South Korea
Contacts
Primary ContactJoo Sung Kim, M.D., PhD
Backup ContactKyoung Sup Hong, M.D.
Outcome results
None listed