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Determination of the Safety and Efficacy of Two Probiotic Strains
Sponsor: The Archer-Daniels-Midland Company
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.
Official title: Determination of the Safety and Efficacy of Two Probiotic Strains in Adults With Mild to Moderate Gastrointestinal Discomfort
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-06
Completion Date
2026-05
Last Updated
2024-06-20
Healthy Volunteers
Yes
Conditions
Interventions
Placebo 1 to Probiotic A
42 day Crossover study design between Placebo 1 and Probiotic A (n = 25)
Probiotic A to Placebo 1
42 day Crossover study design between Probiotic A and Placebo 1 (n = 25)
Placebo 2 to Probiotic B
42 day Crossover study design between Placebo 2 and Probiotic B (n = 25)
Probiotic B to Placebo 2
42 day Crossover study design between Probiotic B and Placebo 2 (n = 25)