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Survival of the Probiotic Lacticaseibacillus Paracasei Strain Shirota (LcS) in the GI Tract of Healthy Adults

NCT05522777 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-12-06

Study results available
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Summary

The objective of this study is to investigate the survival of Lacticaseibacillus paracasei strain Shirota (LcS) in the human gastrointestinal (GI) tract after consumption of probiotics fermented milk product containing 8x10\^9 LcS. This study is a single-arm, open-label study with a 14-d run-in (baseline), 14-d consumption period, and 14-d follow-up. Participants will maintain habitual dietary and lifestyle practices with the exception of avoiding fermented foods and beverages throughout the 42-d trial. The number of live LcS in fecal samples will be assessed after 14 d consumption of a fermented milk product.

Conditions

  • Healthy

Interventions

OTHER

Drink one bottle of Yakult a day

Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota

Sponsors & Collaborators

  • Biofortis Clinical Research, Inc.

    collaborator INDUSTRY

  • Illinois Institute of Technology

    collaborator OTHER

  • Yakult U.S.A. Inc.

    lead INDUSTRY

Principal Investigators

  • Dawn Beckman, MD · Biofortis Clinical Research, Inc.

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2022-10-28
Completion
2023-01-13

Countries

  • United States

Study Locations

More Related Trials

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 NCT05522777 on ClinicalTrials.gov