Effect of L. Paracasei Strain Shirota on Constipation in Healthy US Adults
NCT06014008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-10-22
Summary
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.
Conditions
Interventions
- OTHER
-
Test product consumption group
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.
Sponsors & Collaborators
-
BioFortis
collaborator OTHER -
Dieta Inc.
collaborator UNKNOWN -
Yakult U.S.A. Inc.
lead INDUSTRY
Principal Investigators
-
Aditi Shah, MD · BioFortis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-09-18
- Primary Completion
- 2024-05-13
- Completion
- 2024-09-30
Countries
- United States
Study Locations
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