The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
NCT ID: NCT01161784
Last Updated: 2010-07-14
Study Results
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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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2010-01-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nutrient drink
Nutrient drink
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
Probiotics
Probiotics fermented milk
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
Nutrient drink
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
Eligibility Criteria
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Inclusion 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Malaya
OTHER
National University of Malaysia
OTHER
IMU University, Malaysia
OTHER
Responsible Party
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International Medical University
Locations
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International Medical University
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Other Identifiers
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IMU RO52/2009
Identifier Type: -
Identifier Source: org_study_id
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