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
Bibliographic record
Abstract
BACKGROUND: Lacticaseibacillus paracasei strain Shirota (LcS) has shown benefits for stool consistency in populations with certain bowel complaints (e.g., constipation), but data in a United States population are limited. OBJECTIVES: This study evaluated the effects of LcS on hard or lumpy stools (HLS) in an otherwise healthy population that generally represents the United States adult demographic. METHODS: colony forming units LcS/mL for 28 d (active group) or no intervention (control group) followed by a 14-d postintervention period. Bowel habits were recorded daily using a novel smartphone application. The primary endpoint was the presence of HLS in ≥25% of the participant-rated BMs using the Bristol Stool Form Scale over the 28-d intervention. Secondary endpoints included the presence of reduced frequency of BMs with HLS from baseline, stool frequency, straining, incomplete evacuation, artificial intelligence-derived stool image scores, and Patient Assessment of Constipation Quality of Life (PAC-QOL) scores. RESULTS: The active group showed a significantly lower proportion of participants with HLS in ≥25% of BMs [odds ratio: 0.34; 95% confidence interval (CI): 0.14, 0.80; P = 0.014] along with a higher proportion of participants with a reduced frequency of BMs with HLS from baseline (odds ratio: 2.86; 95% CI: 1.03, 7.92; P = 0.043). The active group also demonstrated positive improvements in total PAC-QOL scores (P = 0.003). CONCLUSIONS: Daily consumption of LcS-containing fermented milk significantly reduced constipation symptoms and improved quality of life in an otherwise generally healthy United States adult population with a history of intermittent BMs producing HLS. The intervention was well tolerated, with no serious adverse events related to the product, suggesting its safety and potential as a dietary strategy for managing constipation. TRIAL REGISTRATION NUMBER: This trial was registered at clinicaltrials.gov as NCT06014008 (https://clinicaltrials.gov/study/NCT06014008).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".