Fermented milk containing Lactobacillus casei strain Shirota reduces incidence of hard or lumpy stools in healthy population

Abstract

The objective of the present study was to investigate the efficacy of fermented milk containing Lactobacillus casei strain Shirota (LcS) in a healthy population. Healthy subjects with Bristol Stool Form Scale (BS) score < 3.0 were randomized to fermented milk treatment for 3 weeks or non-intervention control. The primary endpoint was the proportion of subjects that produced hard or lumpy stools (HLS) ≥ 25% of bowel movements (H-HLS). Secondary endpoints included changes in BS score, constipation-related symptom scores and stool parameters. Efficacy was analyzed in 39 subjects. After 3 weeks of treatment the proportion of H-HLS subjects had significantly decreased from 73.7% to 36.8%, whereas in the control group the proportion had increased from 75.0% to 85.0% during the same period (P = 0.002). The BS score was significantly improved after the treatment compared with the control (P < 0.001). In conclusion, daily consumption of fermented milk containing LcS reduced the incidence of HLS.

Keywords::

• Probiotics
• stool consistency
• Bristol Stool Form Scale
• hard or lumpy stools
• constipation

Acknowledgements

Study coordination, monitoring, data management and statistical analysis were performed by the staff of Omnicare Clinical Research, Inc. (King of Prussia, USA). Recruitment and management of subjects were performed by the staff of Drug Research Unit Ghent, represented by Prof. Dr Luc Van Bortel.

Declarations of interest: The study product was arranged by Dr Bart Degeest of Yakult Belgium NV/SA (Brussels, Belgium). The study was funded by the Yakult Honsha European Research Center for Microbiology ESV (Ghent, Belgium).