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

NCT ID: NCT01088971

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Duolac 7S

Group Type ACTIVE_COMPARATOR

Duolac7S

Intervention Type DIETARY_SUPPLEMENT

1 capsule two times everyday for 6 weeks

starch capsule

Group Type PLACEBO_COMPARATOR

starch

Intervention Type DIETARY_SUPPLEMENT

1capsule two times everyday for 6 weeks

Interventions

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Duolac7S

1 capsule two times everyday for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

starch

1capsule two times everyday for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cell Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University College of Medicine, Gangnam Severance Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CellBiotech

Identifier Type: -

Identifier Source: org_study_id