The Effects of Soy Dietary Fiber in Adults With Diarrhea... | NCT01373034

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

NCT01373034

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jun 14, 2011Estimated

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Interventions

Soy Dietary Fiber
Rice powder

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Jun 13, 2011

First Submission Date that Met QC Criteria

Jun 13, 2011

First Posted Date

Jun 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2011

Last Update Posted Date

Jun 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Soy Dietary Fiber	Experimental		Dietary Supplement: Soy Dietary Fiber
Rice powder	Placebo Comparator		Dietary Supplement: Rice powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Soy Dietary Fiber	Dietary Supplement	Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL	Soy Dietary Fiber

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Joo Sung Kim, M.D., PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea