Colonization, AsymptomaticProbiotic InterventionGut Microbiota Diversity and CompositionGut-brain Axis
Investigational drug(s) / intervention(s)
Microencapsulated Lactobacillus rhamnosus Fruit SnackPlacebo Fruit Snack
Microencapsulated Lactobacillus rhamnosus Fruit Snack: Participants consume one 28-gram fruit snack daily containing microencapsulated Lactobacillus rhamnosus at a concentration of 2 × 10⁹ CFU/g, providing a total daily dose of approximately 5.6 × 10¹⁰ CFU (56 billion CFU/day). The probiotic is delivered in a plant protein-based microencapsulation matrix designed to enhance survival through the gastrointestinal tract and support delivery to the intestine.
Arm 1: Probiotic then Placebo intervention.
Placebo Fruit Snack: Participants daily consume one 28-gram fruit snack daily that is identical in appearance, taste, and texture to the active product but does not contain probiotic bacteria. The placebo snack contains the same base ingredients without Lactobacillus rhamnosus.
Arm 2: Placebo then Probiotic intervention.
Study summary
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.
Eligibility
Sex
ALL
Min age
25 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Signed informed consent prior to any study-related procedure Age 25-65 years-old
* BMI range 18.5-31.9 kg/m2
* Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages)
* Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study
Exclusion Criteria:
* Smoking
* Substance abuse
* Pregnancy and lactaction
* Diagnosis of type 1 and/or type 2 diabetes
* Current (or within the last 4 weeks prior to study start) use of probiotic supplementation.
* Immobile (defined as the inability to participate in all study-related procedures)
* People with intellectual disabilities.
* History of complicated gastrointestinal surgery
* Diagnosed inflammatory bowel disease (IBD)
* Current diagnosis of psychiatric disease/s or syndromes
* Current diagnosis of neurodegenerative disease
* Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
* Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months
* Consumption of any NSAID within 7 days of study start
* Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) or in any other way with the outcome of the study, as decided by the principle investigator's discretion
* Regular smoking, use of snuff, nicotine, cannabidiol narcotics/supplements, or e-cigarette use
* Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
* Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
* After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis.
Justification: it is necessary to exclude participation from individuals with smoking or substance abuse as that may compromise the physiological gut response.
Primary outcome measure(s)
Change in faecal abundance of Lactobacillus rhamnosus — Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period). Stool samples will be collected at four time points: baseline (pre-intervention), end of the first 28-day intervention period, end of the washout period (Day 42), and end of the second 28-day intervention period (Day 70). The abundance of Lactobacillus rhamnosus will be quantified using strain-specific molecular and/or sequencing-based microbiome analysis methods. Changes in abundance will be compared between probiotic and placebo intervention periods in a crossover design.
Trial sites (1)
Facility
City
Region
Status
Clinical Research Centre, St. Vincent's University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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