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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06014008 on ClinicalTrials.gov