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

Primary Purpose

Diarrhea Predominant Irritable Bowel Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Soy Dietary Fiber

Rice powder

About this trial

This is an interventional treatment trial for Diarrhea Predominant Irritable Bowel Syndrome

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Soy Dietary Fiber

Rice powder

Arm Description

Outcomes

Primary Outcome Measures

sum of irritable bowel syndrome symptom score

abdominal pain / abdominal discomfort urgency tenesmus abdominal distension

Secondary Outcome Measures

irritable bowel syndrome symptom score

abdominal pain / abdominal discomfort urgency tenesmus abdominal distension

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)

Symptom control of irritable bowel syndrome

Improvement of overall symptom in patient with irritable bowel syndrome

Severity of overall symptom in patient with irritable bowel syndrome

Severity of diarrhea

Assessment for quality of life related with irritable bowel syndrome

Assessment for patient satisfaction after administration completion

Overall satisfaction for treatment Whether the patient will keep up treatment

Full Information

NCT ID

NCT01373034

First Posted

June 13, 2011

Last Updated

June 13, 2011

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01373034

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea Predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Soy Dietary Fiber

Arm Type

Experimental

Arm Title

Rice powder

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Soy Dietary Fiber

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Rice powder

Intervention Description

Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL

Primary Outcome Measure Information:

Title

sum of irritable bowel syndrome symptom score

Description

abdominal pain / abdominal discomfort urgency tenesmus abdominal distension

Time Frame

after 4 weeks

Secondary Outcome Measure Information:

Title

irritable bowel syndrome symptom score

Description

abdominal pain / abdominal discomfort urgency tenesmus abdominal distension

Time Frame

after 2 weeks and 4 weeks

Title

Stool frequency and form

Description

Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)

Time Frame

after 2 weeks and 4 weeks

Title

Symptom control of irritable bowel syndrome

Time Frame

after 2 weeks and 4 weeks

Title

Improvement of overall symptom in patient with irritable bowel syndrome

Time Frame

after 2 weeks and 4 weeks

Title

Severity of overall symptom in patient with irritable bowel syndrome

Time Frame

after 2 weeks and 4 weeks

Title

Severity of diarrhea

Time Frame

after 2 weeks and 4 weeks

Title

Assessment for quality of life related with irritable bowel syndrome

Time Frame

after 2 weeks and 4 weeks

Title

Assessment for patient satisfaction after administration completion

Description

Overall satisfaction for treatment Whether the patient will keep up treatment

Time Frame

after 2 weeks and 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joo Sung Kim, M.D., PhD

Phone

+82-2-740-8112

jooskim@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Kyoung Sup Hong, M.D.

Phone

+82-10-2578-5738

kshong1@empas.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo Sung Kim, M.D., PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joo Sung Kim, M.D., PhD

Phone

+82-2-740-8112

jooskim@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Kyoung Sup Hong, M.D.

Phone

+82-10-2578-5738

kshong1@empas.com

12. IPD Sharing Statement

Learn more about this trial

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

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