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
80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
International Medical University
Kuala Lumpur, Kuala Lumpur, Malaysia
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
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
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