The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome
1 other identifier
interventional
36
1 country
1
Brief Summary
The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 14, 2011
June 1, 2011
1 year
June 13, 2011
June 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
sum of irritable bowel syndrome symptom score
abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
after 4 weeks
Secondary Outcomes (8)
irritable bowel syndrome symptom score
after 2 weeks and 4 weeks
Stool frequency and form
after 2 weeks and 4 weeks
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
- +3 more secondary outcomes
Study Arms (2)
Soy Dietary Fiber
EXPERIMENTALRice powder
PLACEBO COMPARATORInterventions
Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL
Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL
Eligibility Criteria
You may qualify if:
- willing to consent/undergo necessary procedures
- between the age of 19 and 75 years
- diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Joo Sung Kim, M.D., PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 13, 2011
First Posted
June 14, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 14, 2011
Record last verified: 2011-06