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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Probiotics fermented milk
Nutrient drink
Sponsored by
International Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Functional constipation, Probiotic, Probiotic microorganism, Lactobacillus casei Shirota (LcS)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • International Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Nutrient drink

Probiotics

Arm Description

Outcomes

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)
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation: Severity of false alarms Frequency of less than 3 defecations / week Severity of sensation of incomplete bowel movement Severity of lumpy or hard stools Severity of bloating Frequency of laxative use
Frequency of bowel movement

Secondary Outcome Measures

Stool consistency based on modified Bristol Stool scale
Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5.
Stool output quantity estimations
Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball.

Full Information

First Posted
July 13, 2010
Last Updated
July 13, 2010
Sponsor
International Medical University
Collaborators
University of Malaya, National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01161784
Brief Title
The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
Official Title
The Effects of a Probiotic Fermented Milk on Functional Constipation in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Medical University
Collaborators
University of Malaya, National University of Malaysia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Functional constipation, Probiotic, Probiotic microorganism, Lactobacillus casei Shirota (LcS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrient drink
Arm Type
Placebo Comparator
Arm Title
Probiotics
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics fermented milk
Intervention Description
80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrient drink
Intervention Description
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
Primary Outcome Measure Information:
Title
Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)
Description
Constipation severity score is patient self-assessment of 6 signs and symptoms of constipation: Severity of false alarms Frequency of less than 3 defecations / week Severity of sensation of incomplete bowel movement Severity of lumpy or hard stools Severity of bloating Frequency of laxative use
Time Frame
4 weeks
Title
Frequency of bowel movement
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Stool consistency based on modified Bristol Stool scale
Description
Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5.
Time Frame
4 weeks
Title
Stool output quantity estimations
Description
Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
International Medical University
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
57000
Country
Malaysia

12. IPD Sharing Statement

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

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