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

NCT01161784 | Completed Phase 3 DMC

• 1 other identifier: IMU RO52/2009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Functional constipation; Probiotic; Probiotic microorganism; Lactobacillus casei Shirota (LcS)

Outcome Measures

Primary Outcomes (2)

• 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: 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

  4 weeks

• Frequency of bowel movement

  4 weeks

Secondary Outcomes (2)

• Stool consistency based on modified Bristol Stool scale

  4 weeks

• Stool output quantity estimations

  4 weeks

Study Arms (2)

Nutrient drink

PLACEBO COMPARATOR

Dietary Supplement: Nutrient drink

Probiotics

EXPERIMENTAL

Dietary Supplement: Probiotics fermented milk

Interventions

Probiotics fermented milk DIETARY_SUPPLEMENT

80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks

Probiotics

Nutrient drink DIETARY_SUPPLEMENT

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

Nutrient drink

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IMU University, Malaysia: lead
• University of Malaya: collaborator
• National University of Malaysia: collaborator

Study Sites (1)

International Medical University

Kuala Lumpur, Kuala Lumpur, 57000, Malaysia

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 14, 2010

Record last verified: 2010-07

Locations

MY (1)