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

The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Soy Dietary Fiber; Dietary supplement: Rice powder

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joo Sung Kim, M.D., PhD; Phone Number: +82-2-740-8112; Email: jooskim@snu.ac.kr
• Study Contact Backup: Name: Kyoung Sup Hong, M.D.; Phone Number: +82-10-2578-5738; Email: kshong1@empas.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
    • Contact: Joo Sung Kim, M.D., PhD; Phone Number: +82-2-740-8112; Email: jooskim@snu.ac.kr
    • Contact: Kyoung Sup Hong, M.D.; Phone Number: +82-10-2578-5738; Email: kshong1@empas.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sum of irritable bowel syndrome symptom score	abdominal pain / abdominal discomfort urgency tenesmus abdominal distension	after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
irritable bowel syndrome symptom score	abdominal pain / abdominal discomfort urgency tenesmus abdominal distension	after 2 weeks and 4 weeks
Stool frequency and form	Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)	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
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	Overall satisfaction for treatment Whether the patient will keep up treatment	after 2 weeks and 4 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: CHUNG_SOY