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| Name | Class |
|---|---|
| BioFortis | OTHER |
| Dieta Inc. | UNKNOWN |
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The objective of this study is to investigate the efficacy of daily consumption of a fermented milk containing LcS in reducing the frequency of bowel movement with hard or lumpy stools in generally healthy U.S. adult population with intermittent bowel movements producing hard or lumpy stools.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention group | No Intervention | Not taking test product | |
| Test product consumption group | Experimental | Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product consumption group | Other | Participants will take one bottle (80 ml) of Yakult® drink daily for a period of 4 weeks. Yakult is a branded probiotic drink with 8x10^9 CFU Lacticaseibacillus paracasei strain Shirota. Subsequently, a two-week follow-up period will follow. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that produce hard or lumpy stools (Subjectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements. | Compare the odds ratio of active to control of subjects with hard or lumpy stools (BSFS score of 1 or 2 as determined from the participant's self-reported rating) in at least 25% of the weekly bowel movements. | Four-week period from the start to the end of test product consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that produce hard or lumpy stools (Objectively evaluated Bristol stool form scale (BSFS) score of 1 or 2, ) ≥ 25% of bowel movements. | Compare the odds ratio of active to control of subjects with hard or lumpy stools (BSFS score of 1 or 2 as determined by Dieta Health application stool image analysis) in at least 25% of the weekly bowel movements. | Four-week period from the start to the end of test product consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between groups in the Bristol stool form score of the first stool as collected by Dieta Health application stool image analysis after waking up. | Four-week period from the start to the end of test product consumption. | |
| Difference between groups in the fuzziness of the first stool as collected by Dieta Health application stool image analysis after waking up. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditi Shah, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis | Chicago | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40024315 | Derived | Cook CM, Akiyama T, Blonquist T, Mah E, Derrig L, Shibata H. Effect of Daily Consumption of a Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota (LcS) on Stool Consistency in United States Adults with Hard or Lumpy Stools: A Randomized Controlled Trial. J Nutr. 2025 Apr;155(4):1183-1192. doi: 10.1016/j.tjnut.2025.02.021. Epub 2025 Feb 28. |
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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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| Odds ratio of active to control of subjects who had improved hard or lumpy stool ratio from baseline (BSFS score 1 or 2 as determined by Dieta Health application stool image analysis. | Four-week period from the start to the end of test product consumption. |
| Odds ratio of active to control of subjects who had improved hard or lumpy stool ratio from baseline (BSFS score 1 or 2 as determined from the participant's self-reported rating. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the stool consistency as collected by Dieta Health application stool image analysis. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the stool fuzziness as collected by Dieta Health application stool image analysis. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the stool fragmentation as collected by Dieta Health application stool image analysis. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the stool volume as collected by Dieta Health application stool image analysis. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the stool frequency as collected by Dieta Health application stool image analysis. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in total and sub scores of PAC-QOL questionnaire. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the proportion of bowel movements having straining during evacuation. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the proportion of bowel movement having sensation of remaining stool in the rectum after evacuation. | Four-week period from the start to the end of test product consumption. |
| Four-week period from the start to the end of test product consumption. |
| Difference between groups in the fragmentation of the first stool as collected by Dieta Health application stool image analysis after waking up. | Four-week period from the start to the end of test product consumption. |
| Difference between groups in the volume of the first stool as collected by Dieta Health application stool image analysis after waking up. | Four-week period from the start to the end of test product consumption. |
| Clustering analysis on the multivariate data and to identify distinct groups of subjects who receive benefit from the product. | Four-week period from the start to the end of test product consumption. |