The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults

NCT ID: NCT01161784

Last Updated: 2010-07-14

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to determine the effects of daily consumption for 4 weeks of a fermented milk drink containing a live probiotic microorganism, Lactobacillus casei strain Shirota (LcS) compared to a placebo without LcS, among adults with functional constipation.

Detailed Description

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Conditions

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Constipation

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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Nutrient drink

Group Type PLACEBO_COMPARATOR

Nutrient drink

Intervention Type DIETARY_SUPPLEMENT

80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks

Probiotics

Group Type EXPERIMENTAL

Probiotics fermented milk

Intervention Type DIETARY_SUPPLEMENT

80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks

Interventions

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Probiotics fermented milk

80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Nutrient drink

80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with functional constipation based on ROME II criteria
* Has a constipation severity score (Chinese Constipation Questionnaire or CCQ score) of at least 5, which is the cut-off point for constipated subjects (Chan et al, 2005)
* Free of any cardiovascular related diseases, diabetes, cancer, neurological diseases or any other serious illness, not physically or mentally handicapped
* Living in Klang Valley, with no pre-determined plans to be out of town for one week or longer during scheduled intervention period

Exclusion Criteria

* Body Mass Index of less than 16, or 30 and above
* Pregnant
* Regular ingestion of probiotic products within the preceding four weeks
* Regular use of laxatives (average once a week or more)
* Intake of anticholinergics medications or medications against diarrhea or antibiotics in the preceding 1 month
* Persons with milk protein allergy
* Persons with constipation of organic or neurological origin based on health screening
* Persons with alarm features as assessed by physician during health screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role collaborator

National University of Malaysia

OTHER

Sponsor Role collaborator

IMU University, Malaysia

OTHER

Sponsor Role lead

Responsible Party

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International Medical University

Locations

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International Medical University

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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IMU RO52/2009

Identifier Type: -

Identifier Source: org_study_id

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