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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
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 September 30, 2014