# Evaluating the Effect of Lacticaseibacillus paracasei Strain Shirota on the Physical Consistency of Stool in Healthy Participants with Hard or Lumpy Stools: A Double-Blind, Randomized, Placebo-Controlled Study

## TL;DR

This study investigated whether Lacticaseibacillus paracasei Shirota (LcS) can soften stools in healthy individuals with hard or lumpy stools.

## Contribution

The study used a texture analyzer to objectively measure stool consistency in a placebo-controlled trial.

## Key findings

- Stool consistency in the LcS group tended to be softer than in the placebo group (p = 0.052).
- Subgroup analysis showed significantly softer stools in the LcS group for participants with baseline TAXT values ≥ 4.5 (p = 0.014).
- Stool water content was significantly higher in the LcS group compared to the placebo group.

## Abstract

We have earlier established a direct measurement method for assessing stool physical consistency using a texture analyzer (TAXT). The present study aimed to evaluate the stool softening effect of Lacticaseibacillus paracasei strain Shirota (LcS) using TAXT in a double-blind, randomized, placebo-controlled study. Sixty-four healthy participants with a Bristol stool form scale (BSFS) 1/2 ≥ 50% during screening consumed fermented milk containing LcS or a placebo beverage daily for 8 weeks. Stool consistency and water content were determined using TAXT and a lyophilizer, respectively. Participants evaluated their defecation using the BSFS. Stool consistency evaluated by a texture analyzer (TAXT) in the LcS group tended to be softer than that in the placebo group (p = 0.052). Subgroup analyses (TAXT value at baseline ≥ 4.5) showed that stool consistency was significantly softer in the LcS group (p = 0.014). Stool water content was also significantly higher in the LcS group than in the placebo group, but the proportion of normal stools was not statistically significant. We were unable to find evidence for the softening effect of LcS under the present study’s conditions. However, its efficacy may be confirmed by targeting participants with physically hard stools and TAXT values ≥ 4.5.