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The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
This study has been completed.
Sponsor:
International Medical University
Collaborators:
University of Malaya
National University of Malaysia
Information provided by:
International Medical University
ClinicalTrials.gov Identifier:
NCT01161784
First received: July 13, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Constipation | Dietary Supplement: Probiotics fermented milk Dietary Supplement: Nutrient drink | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults |
Resource links provided by NLM:
Further study details as provided by International Medical University:
Primary Outcome Measures:
- Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005) [ Time Frame: 4 weeks ]
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation:
- Severity of false alarms
- Frequency of less than 3 defecations / week
- Severity of sensation of incomplete bowel movement
- Severity of lumpy or hard stools
- Severity of bloating
- Frequency of laxative use
- Frequency of bowel movement [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- Stool consistency based on modified Bristol Stool scale [ Time Frame: 4 weeks ]Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5.
- Stool output quantity estimations [ Time Frame: 4 weeks ]Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball.
| Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Nutrient drink |
Dietary Supplement: Nutrient drink
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
|
| Experimental: Probiotics |
Dietary Supplement: Probiotics fermented milk
80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01161784
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161784
Locations
| Malaysia | |
| International Medical University | |
| Kuala Lumpur, Wilayah Persekutuan, Malaysia, 57000 | |
Sponsors and Collaborators
International Medical University
University of Malaya
National University of Malaysia
More Information
| Responsible Party: | Prof. Dr. Fatimah Arshad, International Medical University |
| ClinicalTrials.gov Identifier: | NCT01161784 History of Changes |
| Other Study ID Numbers: |
IMU RO52/2009 |
| Study First Received: | July 13, 2010 |
| Last Updated: | July 13, 2010 |
Keywords provided by International Medical University:
|
Functional constipation Probiotic Probiotic microorganism Lactobacillus casei Shirota (LcS) |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 26, 2017