The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
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ClinicalTrials.gov Identifier: NCT01161784 |
Recruitment Status
:
Completed
First Posted
: July 14, 2010
Last Update Posted
: July 14, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Constipation | Dietary Supplement: Probiotics fermented milk Dietary Supplement: Nutrient drink | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161784
Malaysia | |
International Medical University | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 57000 |
Responsible Party: | Prof. Dr. Fatimah Arshad, International Medical University |
ClinicalTrials.gov Identifier: | NCT01161784 History of Changes |
Other Study ID Numbers: |
IMU RO52/2009 |
First Posted: | July 14, 2010 Key Record Dates |
Last Update Posted: | July 14, 2010 |
Last Verified: | July 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 |