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

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: Constipation
• Intervention / Treatment: Dietary supplement: Nutrient drink; Dietary supplement: Probiotics fermented milk

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	4 weeks
Frequency of bowel movement		4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: International Medical University
• Collaborators: University of Malaya; National University of Malaysia

Study record dates

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: Probiotic; Functional constipation; Probiotic microorganism; Lactobacillus casei Shirota (LcS)
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: IMU RO52/2009