Effect of Duolac 7S Administration on Improving Symptom i... | NCT01088971

Studies
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome

NCT01088971

Sponsor

Cell Biotech Co., Ltd.

Status

Completed

Last Update Posted

Dec 23, 2011Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Irritable Bowel Syndrome

Interventions

Duolac7S
starch

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Mar 7, 2010

First Submission Date that Met QC Criteria

Mar 16, 2010

First Posted Date

Mar 18, 2010Estimated

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

Dec 22, 2011

Last Update Posted Date

Dec 23, 2011Estimated

Description Module

Brief Summary

Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duolac 7S	Active Comparator		Dietary Supplement: Duolac7S
starch capsule	Placebo Comparator		Dietary Supplement: starch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duolac7S	Dietary Supplement	1 capsule two times everyday for 6 weeks	Duolac 7S

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The improvement of IBS symptoms	IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7).	6 weeks (symptom diary and weekly questionnaire)

Secondary Outcomes

Measure	Description	Time Frame
Changes in fecal microflora		baseline and after 6weeks
Changes of biochemical marker		baseline and after 6weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 18~65 years
diarrhea type irritable bowel syndrome (by ROME III criteria)
no organic bowel disease (by colonoscopy or barium enema)

Exclusion Criteria:

pregnant women or nursing mothers
hypersensitivity to probiotics
congestive heart failure or ischemic heart disease
systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
abdominal surgery (exception: appendectomy, hernia surgery)
more than moderate alcohol drinking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University College of Medicine, Gangnam Severance Hospital		Seoul	Seoul	135-720	South Korea

Type	Date	Date Unknown
Release	May 12, 2012
Reset	Jun 13, 2012

Submission Tracking

Estimated Results First Submitted Date

May 12, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 12, 2012			Jun 13, 2012

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013213	Starch

Ancestor Terms

ID	Term
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided