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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161784
• Other study ID #: IMU RO52/2009
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2010
• Last updated: July 13, 2010
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

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
• Nutrient drink
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks

Locations

Country	Name	City	State
Malaysia	International Medical University	Kuala Lumpur	Wilayah Persekutuan

Sponsors (3)

Lead Sponsor	Collaborator
International Medical University	National University of Malaysia, University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Frequency of bowel movement		4 weeks	No
Secondary	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	No
Secondary	Stool output quantity estimations	Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball.	4 weeks	No