Abstract
- Background
Lacticaseibacillus paracasei strain Shirota (LcS) has shown benefits for stool consistency in populations with certain bowel complaints, such as constipation, but data in a United States population are limited. This study evaluated the effects of LcS on hard or lumpy stools in an otherwise healthy population that generally represents the United States adult demographic.
- Methods
In this randomized, controlled, open-label study, 50 participants (41 females, 9 males) with hard or lumpy stools in at least 25% of bowel movements during a 14-day run-in period were randomly assigned to receive either 80 milliliters of fermented milk containing 8.0 × 10⁹ colony-forming units of LcS per milliliter for 28 days (active group) or no intervention (control group). This was followed by a 14-day post-intervention period. Bowel habits were recorded daily using a smartphone application. The primary endpoint was the presence of hard or lumpy stools in at least 25% of bowel movements using the Bristol Stool Form Scale. Secondary endpoints included stool frequency, straining, incomplete evacuation, artificial intelligence-derived stool image scores, and Patient Assessment of Constipation Quality of Life scores.
- Results
The active group showed a significantly lower proportion of participants with hard or lumpy stools in at least 25% of bowel movements compared to the control group. Additionally, there was a higher proportion of participants in the active group who experienced a reduced frequency of such bowel movements from baseline. The active group also demonstrated significant positive improvements in total quality of life scores related to constipation symptoms.
- 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 hard or lumpy stools. The intervention was well-tolerated, with no serious adverse events related to the product, suggesting its safety and potential as an effective dietary strategy for managing constipation.
https://www.sciencedirect.com/science/article/pii/S0022316625001373