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Probiotic in Fruit Snack

Study acronym: Probiotics
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The aim of this study is to investigate whether a fruit snack containing probiotic ''Lactobacillus rhamnosus'' can survive and establish itself more effectively in the gut when it is protected inside a natural plant-protein coating and delivered in a fruit snack. Lactobacillus rhamnosus is a beneficial bacterium that may support gut health and influence communication between the gut and the brain. In this study, we will examine how the probiotic affects the gut microbiome (the community of bacteria that naturally live in the gut). We are recruiting 25 healthy men and women aged 25-65 years with a body mass index (BMI) between 18.5 and 31.9 kg/m². Participants will be randomly assigned to receive either: A) Fruit snack containing encapsulated Lactobacillus rhamnosus probiotics, or a similar fruit snack that does not contain probiotics (placebo). Neither participants nor researchers (blinded) will know which snack is being provided during the study. Participants will attend four study visits over approximately 10 weeks (70 days): at the baseline visit Day 0 and again at Days 28, Day 42, and Day 70. A blood and stool samples will be collected at the beginning of the study, and samples will be used to assess changes in the gut microbiome over time. The findings from this study will help us better understand how targeted delivery of probiotics to the gut may influence the gut microbiome and support digestive health.
Trial Details
NCT Number NCT07679490
Lead Sponsor University College Dublin
Conditions
(from sponsor)
Colonization, Asymptomatic, Probiotic Intervention, Gut Microbiota Diversity and Composition, Gut-brain Axis
Related terms Asymptomatic Infections
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov