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

International Medical University

Status and phase

Completed

Phase 3

Conditions

Constipation

Treatments

Dietary Supplement: Nutrient drink

Dietary Supplement: Probiotics fermented milk

Study type

Interventional

Funder types

Other

Identifiers

NCT01161784

IMU RO52/2009

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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