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

This study has been completed.

Sponsor:

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

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Constipation

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation:
1. Severity of false alarms
2. Frequency of less than 3 defecations / week
3. Severity of sensation of incomplete bowel movement
4. Severity of lumpy or hard stools
5. Severity of bloating
6. Frequency of laxative use
Frequency of bowel movement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stool consistency based on modified Bristol Stool scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5.
Stool output quantity estimations [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority:	Malaysia: Ministry of Health

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 September 30, 2016

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