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Clinical Trial Summary

The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are: - what is the the rate of gastrointestinal colonisation of food derived bacteria? - what is the contribution of food derived bacteria to gut microbiome stability? Participants will complete a cross over feeding study of dietitian designed meals of known microbial load and will be asked to provide stool and blood samples for analysis.


Clinical Trial Description

To understand the role and stability of food derived bacteria in impacting microbiome composition, 20 healthy participants will be recruited for this single site double blinded randomised controlled crossover pilot trial. The study is divided into four 14 day diet phases - baseline habitual, specified diet 1, habitual washout and specified diet 2. Participants will be randomly assigned to receive a microbial or non-microbial diet in specified diet 1 phase. Each participant will then crossover to receive the alternative diet in the specified diet 2 phase. The microbial and non-microbial diets will be identical except for the removal of naturally occurring food derived bacteria in non-microbial diet. At the commencement of the study and at the end of each diet phase, participants will attend a research clinic to undergo comprehensive clinical and anthropometric assessment and dietary evaluation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05986955
Study type Interventional
Source Monash University
Contact Emma Saltzman
Phone +61439035949
Email emma.saltzman@monash.edu
Status Not yet recruiting
Phase Early Phase 1
Start date September 2023
Completion date December 2023

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