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| Name | Class |
|---|---|
| University of Malaya | OTHER |
| National University of Malaysia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrient drink | Placebo Comparator |
| |
| Probiotics | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 4 weeks |
| Frequency of bowel movement | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool consistency based on modified Bristol Stool scale | Stool consistency is self-assessed by subjects as Type 1,2,3,4 or 5. | 4 weeks |
| Stool output quantity estimations | Stool output is estimated by subjects visually based on comparison to size of a standard ping pong ball. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Medical University | Kuala Lumpur | Kuala Lumpur | 57000 | Malaysia |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Nutrient drink | Dietary Supplement | 80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks |
|
| 4 weeks |