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| Name | Class |
|---|---|
| Bach Mai Hospital | OTHER |
| Vietnam National University | OTHER |
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The objective of this study is to provide evidence supporting the efficacy of fermented milk containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A randomized, controlled trial has been designed on constipated adults with a high prevalence of hard stools in Vietnam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented milk drink | Experimental |
| |
| No drink | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus casei strain Shirota fermented milk | Dietary Supplement | Participants will take one bottle (65 ml) of Yakult® drink daily, containing at least 6.5 x 10^9 CFU of Lactobacillus casei strain Shirota, for a period of 4 weeks. Subsequently, there will be a two-week follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that produce hard or lumpy stools (Bristol stool form scale (BS) score of 1 or 2) ≥ 25% of bowel movements | Overall treatment effect during the intervention period will be estimated using mixed effects logistic regression (with a random intercept) which include "Groups (Yakult/non-treatment)", "Weeks (first/second two weeks of the intervention period)", "baseline (median BS score during baseline)" and "Gender (women/men)" as the independent variables. "Groups x Weeks" interaction will not be included because it was absent in the past RCT studies giving Yakult. | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency with hard or lumpy one (BS score of 1 or 2) | During four weeks from the date of the site visit to submit a baseline stool sample. | |
| Stool frequency with ideal stool (BS score of 4) | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Measure | Description | Time Frame |
|---|---|---|
| BS score of the first stool after waking up (descriptive analysis) | During four weeks from the date of the site visit to submit a baseline stool sample. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinh Van Hoang, PhD | Vietnam National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bach Mai Hospital | Hanoi | 100000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41980711 | Derived | Hoang Van V, Dong Van T, Nguyen Bao N, Nguyen Quynh U, Nguyen Thi Linh C, Dao Xuan C, Akiyama T. Effects of fermented milk containing Lacticaseibacillus paracasei strain Shirota on constipation and gut microbiota: A randomised pilot study in Vietnam. Benef Microbes. 2026 Apr 13:1-14. doi: 10.1163/18762891-bja00116. Online ahead of print. |
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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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| Stool frequency, as measured by a daily stool diary | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Stool frequency with straining during evacuation, as measured by a daily stool diary (Yes/No) | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Stool frequency with sensation of remaining stool in the rectum after the evacuation, as measured by a daily stool diary (Yes/No) | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Stool frequency with sensation of anorectal blockage, as measured by a daily stool diary (Yes/No) | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Stool frequency with which manual maneuvers are used, as measured by a daily stool diary (Yes/No) | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Chinese Constipation Questionnaire score | During four weeks from the date of the site visit to submit a baseline stool sample. |
| Stool microbiota (increase in the abundance of bifidobacteria) | During four weeks from the date of the site visit to submit a baseline stool sample. |