Status:
COMPLETED
The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
Lead Sponsor:
IMU University, Malaysia
Collaborating Sponsors:
University of Malaya
National University of Malaysia
Conditions:
Constipation
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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) com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01161784
Start Date
January 1 2010
End Date
June 1 2010
Last Update
July 14 2010
Active Locations (1)
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1
International Medical University
Kuala Lumpur, Kuala Lumpur, Malaysia, 57000