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

Seoul National University

Status: Unknown

Conditions: Diarrhea Predominant Irritable Bowel Syndrome

Treatments: Dietary Supplement: Rice powder; Dietary Supplement: Soy Dietary Fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT01373034

CHUNG_SOY

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Soy Dietary Fiber

Experimental group

Treatment:

Dietary Supplement: Soy Dietary Fiber

Rice powder

Placebo Comparator group

Treatment:

Dietary Supplement: Rice powder