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

Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01373034
• Other study ID #: CHUNG_SOY
• Status: Not yet recruiting
• Phase: N/A
• First received: June 13, 2011
• Last updated: June 13, 2011
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2011
• Source: Seoul National University Hospital
• Contact: Joo Sung Kim, M.D., PhD
• Phone: +82-2-740-8112
• Email: jooskim[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Soy Dietary Fiber
Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL
• Rice powder
Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sum of irritable bowel syndrome symptom score	abdominal pain / abdominal discomfort urgency tenesmus abdominal distension	after 4 weeks	Yes
Secondary	irritable bowel syndrome symptom score	abdominal pain / abdominal discomfort urgency tenesmus abdominal distension	after 2 weeks and 4 weeks	Yes
Secondary	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	Yes
Secondary	Symptom control of irritable bowel syndrome		after 2 weeks and 4 weeks	Yes
Secondary	Improvement of overall symptom in patient with irritable bowel syndrome		after 2 weeks and 4 weeks	Yes
Secondary	Severity of overall symptom in patient with irritable bowel syndrome		after 2 weeks and 4 weeks	Yes
Secondary	Severity of diarrhea		after 2 weeks and 4 weeks	Yes
Secondary	Assessment for quality of life related with irritable bowel syndrome		after 2 weeks and 4 weeks	Yes
Secondary	Assessment for patient satisfaction after administration completion	Overall satisfaction for treatment Whether the patient will keep up treatment	after 2 weeks and 4 weeks	Yes