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

Phase 3

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Nutrient drink; Dietary Supplement: Probiotics fermented milk

• Registration Number: NCT01161784
• Lead Sponsor: International Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Last Update Submitted: 2010-07-13
• Study First Posted: 2010-07-14
• Last Update Posted: 2010-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrient drink	Nutrient drink	-
Probiotics	Probiotics fermented milk	-

Primary Outcome Measures

Name	Time	Method
Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)	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
Frequency of bowel movement	4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

International Medical University; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia