The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome

NCT ID: NCT01637714

Last Updated: 2013-06-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.

Detailed Description

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Conditions

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Diarrhea Predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multi-strain probiotics

Group Type EXPERIMENTAL

Multi-strain probiotics

Intervention Type DRUG

* B. longum BORI: 1 x 109
* B. bifidum BGN4: 1 x 109
* B. lactis AD011: 1 x 109
* B. infantis IBS007: 1 x 109
* Lactobacillus acidophilus AD031: 1 x 109

three times a day, within 10 minutes after meal, per oral with water

Placebo powder

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type DRUG

same taste, shape, dosage as experimental drug

three times a day, within 10 minutes after meal, per oral with water

Interventions

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Multi-strain probiotics

* B. longum BORI: 1 x 109
* B. bifidum BGN4: 1 x 109
* B. lactis AD011: 1 x 109
* B. infantis IBS007: 1 x 109
* Lactobacillus acidophilus AD031: 1 x 109

three times a day, within 10 minutes after meal, per oral with water

Intervention Type DRUG

Placebo powder

same taste, shape, dosage as experimental drug

three times a day, within 10 minutes after meal, per oral with water

Intervention Type DRUG

Eligibility Criteria

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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 \> 180/110 mmHg)
* uncontrolled diabetes mellitus (FBS \> 200 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
* serum Cr \> 2 x Upper normal limit
* AST or ALT \> 2 x Upper normal limit
* Pregnancy, Lactating woman
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joo Sung Kim, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joo Sung Kim, M.D., PhD

Role: CONTACT

+82-2-740-8112

Kyoung Sup Hong, M.D.

Role: CONTACT

+82-10-2578-5738

Facility Contacts

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Joo Sung Kim, M.D.,PhD

Role: primary

+82-2-740-8112

Kyoung Sup Hong, M.D.

Role: backup

+82-10-2578-5738

Other Identifiers

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Probiotics for IBS

Identifier Type: -

Identifier Source: org_study_id

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