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Determination of the Safety and Efficacy of Two Probiotic Strains

NCT06466174 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-20

No results posted yet for this study

Summary

The goal of this study is to determine the safety and efficacy of two probiotic strains in adults with mild to moderate gastrointestinal discomfort. The main questions it aims to answer is whether 6-week administration of a probiotic can improve how the participant feels regarding their gut health. This is done by completing a weekly questionnaire and the results are compared between the 6 weeks the participants are on a placebo and the 6 weeks the participants are on the probiotic. Participants will also provide a blood sample, and stool sample at the start and end of each treatment. Similarly, the results from the blood samples and stool samples will be analysed to determine if there is any improvement in markers related to gut health.

Conditions

  • Gastrointestinal Dysfunction

Interventions

DIETARY_SUPPLEMENT

Placebo 1 to Probiotic A

42 day Crossover study design between Placebo 1 and Probiotic A (n = 25)

DIETARY_SUPPLEMENT

Probiotic A to Placebo 1

42 day Crossover study design between Probiotic A and Placebo 1 (n = 25)

DIETARY_SUPPLEMENT

Placebo 2 to Probiotic B

42 day Crossover study design between Placebo 2 and Probiotic B (n = 25)

DIETARY_SUPPLEMENT

Probiotic B to Placebo 2

42 day Crossover study design between Probiotic B and Placebo 2 (n = 25)

Sponsors & Collaborators

  • Merieux NutriSciences (China)

    collaborator UNKNOWN

  • The Archer-Daniels-Midland Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-05-31
Completion
2026-05-31

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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 NCT06466174 on ClinicalTrials.gov