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

IMU University, Malaysia100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Constipation

Interventions

Probiotics fermented milkDIETARY_SUPPLEMENT

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

Nutrient drinkDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

International Medical University

Kuala Lumpur, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

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

Time frame: 4 weeks

Frequency of bowel movement

Time frame: 4 weeks

Secondary Outcomes

Stool consistency based on modified Bristol Stool scale

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

Time frame: 4 weeks

Stool output quantity estimations

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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