Probiotic in Fruit Snack

NCT07679490 | Active Not Recruiting DMC

• 1 other identifier: RS24-010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonization, Asymptomatic; Probiotic Intervention; Gut Microbiota Diversity and Composition; Gut-brain Axis

Keywords

Probiotics; L.rhamnosus; gut microbiome; gastrointestinal health; microencapsulated probiotics

Outcome Measures

Primary Outcomes (1)

• Change in faecal abundance of Lactobacillus rhamnosus

  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.

  Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period).

Secondary Outcomes (6)

• Serum serotonin concentration

  Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)

• Serum brain-derived neurotrophic factor (BDNF)

  Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)

• Inflammatory cytokine (IL-6) concentration

  Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)

• Inflammatory cytokine (IL-10) concentration

  Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)

• Inflammatory cytokine (TNF-alpha)

  Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)

Study Arms (2)

Experimental Arm 1

ACTIVE COMPARATOR

Participants receive the fruit snack containing microencapsulated Lactobacillus rhamnosus for 28 days, followed by a 14-day washout period and then the placebo fruit snack for 28 days.

Dietary Supplement: Microencapsulated Lactobacillus rhamnosus Fruit Snack

Experimental Arm 2

PLACEBO COMPARATOR

Participants receive the placebo fruit snack for 28 days, followed by a 14-day washout period and then the fruit snack containing microencapsulated Lactobacillus rhamnosus for 28 days.

Dietary Supplement: Placebo Fruit Snack

Interventions

Microencapsulated Lactobacillus rhamnosus Fruit Snack DIETARY_SUPPLEMENT

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.

Also known as: Probiotic fruit snack, Lactobacillus rhamnosus encapsulated snack

Experimental Arm 1

Placebo Fruit Snack DIETARY_SUPPLEMENT

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.

Also known as: Non-probiotics fruit snack, control fruit snack

Experimental Arm 2

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

Clinical Research Centre, St. Vincent's University Hospital

Dublin, Dublin 04, D04 T6F4, Ireland

Location

Related Publications (16)

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  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Asymptomatic Infections

Condition Hierarchy (Ancestors)

Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two treatment sequences in a double-blind crossover design. During one intervention period, participants will daily consume a fruit snack containing microencapsulated Lactobacillus rhamnosus, and during the other intervention period they will consume a matched fruit snack without probiotics (placebo). Each intervention period will last 28 days and will be separated by a 14-day washout period. Participants and study investigators will remain blinded to treatment allocation throughout the study. This design allows each participant to serve as their own control, reducing inter-individual variability when assessing probiotic colonisation and changes in gut microbiome composition. Randomisation will be performed by an independent research investigator who is not involved in the study activities.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: January 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)