The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome
This study is not yet open for participant recruitment.
Verified June 2011 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01373034
First received: June 13, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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Purpose
The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.
| Condition | Intervention |
|---|---|
|
Diarrhea Predominant Irritable Bowel Syndrome |
Dietary Supplement: Soy Dietary Fiber Dietary Supplement: Rice powder |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- sum of irritable bowel syndrome symptom score [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ]abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
Secondary Outcome Measures:
- irritable bowel syndrome symptom score [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]abdominal pain / abdominal discomfort urgency tenesmus abdominal distension
- Stool frequency and form [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
- Improvement of overall symptom in patient with irritable bowel syndrome [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
- Severity of overall symptom in patient with irritable bowel syndrome [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
- Severity of diarrhea [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
- Assessment for quality of life related with irritable bowel syndrome [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]
- Assessment for patient satisfaction after administration completion [ Time Frame: after 2 weeks and 4 weeks ] [ Designated as safety issue: Yes ]Overall satisfaction for treatment Whether the patient will keep up treatment
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Soy Dietary Fiber |
Dietary Supplement: Soy Dietary Fiber
Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL
|
| Placebo Comparator: Rice powder |
Dietary Supplement: Rice powder
Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL
|
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373034
Contacts
| Contact: Joo Sung Kim, M.D., PhD | +82-2-740-8112 | jooskim@snu.ac.kr |
| Contact: Kyoung Sup Hong, M.D. | +82-10-2578-5738 | kshong1@empas.com |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Joo Sung Kim, M.D., PhD +82-2-740-8112 jooskim@snu.ac.kr | |
| Contact: Kyoung Sup Hong, M.D. +82-10-2578-5738 kshong1@empas.com | |
Sponsors and Collaborators
Seoul National University Hospital
Investigators
| Principal Investigator: | Joo Sung Kim, M.D., PhD | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Kyoung Sup Hong, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01373034 History of Changes |
| Other Study ID Numbers: | CHUNG_SOY |
| Study First Received: | June 13, 2011 |
| Last Updated: | June 13, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Diarrhea Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013