The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome

Not Applicable

• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Soy Dietary Fiber; Dietary Supplement: Rice powder

• Registration Number: NCT01373034
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-13
• Last Update Submitted: 2011-06-13
• Study First Posted: 2011-06-14
• Last Update Posted: 2011-06-14
• Study Start: 2011-07
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soy Dietary Fiber	Soy Dietary Fiber	-
Rice powder	Rice powder	-

Primary Outcome Measures

Name	Time	Method
sum of irritable bowel syndrome symptom score	after 4 weeks	abdominal pain / abdominal discomfort urgency tenesmus abdominal distension

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of