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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:

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
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
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

No publications provided

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 May 23, 2013