Constipation
Conditions
Keywords
Functional constipation, Probiotic, Probiotic microorganism, Lactobacillus casei Shirota (LcS)
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.
Interventions
DIETARY_SUPPLEMENTProbiotics fermented milk
80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
DIETARY_SUPPLEMENTNutrient drink
80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
Sponsors
University of Malaya
National University of Malaysia
IMU University, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Malaysia
Outcome results
None listed