Skip to main content
OpenTrials
Completed

NCT Number: NCT01161784

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

International Medical University

Kuala Lumpur, 57000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Nutrient drink

Dietary Supplement

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

Primary outcomes

  1. Constipation severity score which measures overall signs and symptoms of constipation using the 'Chinese Constipation Questionnaire' or CCQ (Chan et al, 2005)

    Time frame: 4 weeks

    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

  2. Frequency of bowel movement

    Time frame: 4 weeks

Secondary outcomes

  1. Stool consistency based on modified Bristol Stool scale

    Time frame: 4 weeks

    Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5.

  2. Stool output quantity estimations

    Time frame: 4 weeks

    Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball.

Sponsors and collaborators

Lead sponsor

IMU University, Malaysia

Other

Collaborators

  • National University of Malaysia
  • University of Malaya

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 14, 2010
Registry last updated
Jul 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.