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

Study Description

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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) compared to a placebo without LcS, among adults with functional constipation.

Condition or disease	Intervention/treatment	Phase
Constipation	Dietary Supplement: Probiotics fermented milk; Dietary Supplement: Nutrient drink	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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:

   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
2. Frequency of bowel movement [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	July 14, 2010
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