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A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults

NCT04223388 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-10

No results posted yet for this study

Summary

Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 28-days. Three check-in visits will occur every 7 days of study participation. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Blood samples, stool samples, and questionnaires will be completed for study outcome analysis.

Conditions

  • Gastrointestinal Health
  • Healthy

Interventions

DIETARY_SUPPLEMENT

Lactobacillus plantarum 276

5 Billion CFU/dose, serving size = 1 capsule/day

OTHER

Placebo

Placebo product, serving size = 1 capsule/day

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Canada

Study Locations

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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 NCT04223388 on ClinicalTrials.gov