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

This study has been completed.
University of Malaya
National University of Malaysia
Information provided by:
International Medical University Identifier:
First received: July 13, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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
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:

    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 ]

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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01161784

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 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 microorganism
Lactobacillus casei Shirota (LcS)

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on May 23, 2017