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

July 13, 2010 updated by: International Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 57000
        • International Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
PLACEBO_COMPARATOR: Nutrient drink
Dietary supplement: Nutrient drink
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
Frequency of bowel movement
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Medical University

Collaborators

University of Malaya
National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (ESTIMATE)

July 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2010

Last Update Submitted That Met QC Criteria

July 13, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMU RO52/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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