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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-06-084-CT-R1 | Other Identifier | University of Santo Tomas REC |
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| Name | Class |
|---|---|
| Yakult Honsha Co., LTD | INDUSTRY |
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The primary purpose of this study is to investigate whether the consumption of a probiotic drink (with Lacticaseibacillus paracasei strain Shirota (LcS)) relieves constipation-related symptoms of Filipino adults, specifically its effect on stool consistency, frequency, and duration, and on gastrointestinal discomfort.
The goal of this clinical trial is to test if probiotic drink with LcS consumption can improve constipation-related symptoms. The main question[s] it aims to answer are:
Participants will consume probiotic drink with LcS once a day for four weeks while maintaining their usual physical activity. Researchers will compare the control group and the probiotic group to see if there are differences in stool consistency, frequency and duration, and gastrointestinal symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Probiotic drink with Lacticaseibacillus paracasei strain Shirota will be consumed once per day for four weeks. Brochure containing recommendations to improve constipation will be provided at the start of study. |
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| Control | Placebo Comparator | Brochure containing recommendations to improve constipation will be provided at the start of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Probiotic with LcS | Other | Probiotic drink with LcS will be consumed once per day for four weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in stool consistency | Bristol Stool Consistency Score: Type 1: Separate hard lumps, like nuts (hard to pass); Severe Constipation. Type 2: Sausage-shaped, but lumpy; Mild Constipation. Type 3: Like a sausage, but with cracks on its surface; Normal. Type 4: Like a sausage or snake, smooth and soft; Normal. Type 5: Soft blobs with clear-cut edges (passed easily); Borderline Normal. Type 6: Fluffy pieces with ragged edges, a mushy stool; Mild diarrhea. Type 7: Watery, no solid pieces, entirely liquid; Severe diarrhea. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Frequency of Bowel Movement | Frequency of Bowel Movement- recorded as the number of bowel movements per day and reported as the daily average bowel movement in a week | four weeks |
| Change in the Duration of Bowel Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane S Mendoza-Sarmiento, Ph.D | Contact | +639088738336 | dsmendoza@ust.edu.ph | |
| Nicole Kate D Sison, MS in Food Science | Contact | +639613634908 | ndsison@ust.edu.ph |
| Name | Affiliation | Role |
|---|---|---|
| Diane S MENDOZA-SARMIENTO, Ph.D in Health Research | University of Santo Tomas | Principal Investigator |
| Leslie Michelle M Dalmacio, Ph.D in Molecular Biology | University of the Philippines-Manila | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Santo Tomas | Recruiting | Manila | Manila | 1015 | Philippines |
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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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Data encoder, Statistician
| Control | Other | Brochure containing recommendations to improve constipation will be provided at start of study. |
|
Duration of Bowel movement will be recorded in minutes in the lavatory per bowel movement per day and reported as the daily average minutes in a week.
| Four weeks |
| Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms) | This includes measures of abdominal discomfort and pain, painful bowel movement, bloating, a sense of incomplete bowel movement, straining during bowel movement, and unsuccessful bowel movement using a five-point scale (PAC-SYM). | four weeks |