Probiotic in Fruit Snack (NCT07679490) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Probiotic in Fruit Snack
Ireland25 participantsStarted 2026-01-18
Plain-language 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.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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'…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in faecal abundance of Lactobacillus rhamnosus
Timeframe: Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period).