Colonization, AsymptomaticProbioticsNCT07679490
Probiotic in Fruit Snack
A study testing Microencapsulated Lactobacillus rhamnosus Fruit Snack in people with Colonization, Asymptomatic and Probiotic Intervention, run by University College Dublin at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonization, Asymptomatic, Probiotic Intervention, Gut Microbiota Diversity and Composition
- What is being tested?
- Microencapsulated Lactobacillus rhamnosus Fruit Snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIreland
- Study dates
- 18 Jan 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Clinical Research Centre, St. Vincent's University Hospital
Dublin, Dublin 04, D04 T6F4
About this study
Official title: A Physiological Study of a Fruit Snack Containing Probiotics
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).
Read more
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:
- 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.
Read the detailed description
The gut microbiota plays an important role in human health through interactions with the gastrointestinal, immune, endocrine, and nervous systems. Increasing evidence suggests that the gut microbiota influences gastrointestinal and brain function through the microbiota-gut-brain axis, a bidirectional communication network linking the gastrointestinal tract and the central nervous system. Alterations in gut microbial composition have been associated with aging-related physiological changes, gastrointestinal function, inflammation, cognition, and mood.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. However, the effectiveness of probiotic supplementation depends on the ability of viable microorganisms to survive food processing, storage, gastric acidity, and gastrointestinal transit before reaching their target site in the intestine. Consequently, strategies that improve probiotic survival and targeted delivery may enhance intestinal colonisation and biological activity within the gastrointestinal tract.
Microencapsulation is a promising approach for protecting probiotic bacteria during manufacturing, storage, and passage through the upper gastrointestinal tract. Encapsulation within a protective plant protein matrix may increase delivery of viable probiotic cells to the intestine by reducing exposure to gastric acid and digestive enzymes. The investigational product used in this study contains Lactobacillus rhamnosus microencapsulated using a plant protein-based delivery system and incorporated into a fruit snack.
The primary objective of this study is to determine whether daily consumption of a fruit snack containing microencapsulated Lactobacillus rhamnosus increases intestinal colonisation compared with a matched fruit snack without probiotics. Colonisation will be assessed by measuring the abundance of Lactobacillus rhamnosus in stool samples.
Secondary objectives include evaluating the effects of the intervention on gut microbiome composition and diversity, and exploring changes in markers related to gastrointestinal function and microbiota-gut-brain axis physiology.
This study is a randomised, double-blind, placebo-controlled crossover trial. Participants will complete two 28-day intervention periods separated by a 14-day washout period. Participants will receive both study interventions in a random order: (1) a fruit snack containing microencapsulated Lactobacillus rhamnosus and (2) a matched fruit snack without probiotics.
Participants will consume one 28-g serving of the assigned fruit snack each day during each intervention period. The probiotic snack contains Lactobacillus rhamnosus at a concentration of 2 × 10⁹ colony-forming units (CFU) per gram, providing a total daily dose of approximately 5.6 × 10¹⁰ CFU (56 billion CFU/day). Stool samples will be collected at predefined study visits to assess probiotic colonisation and changes in gut microbiome composition.
This study will provide evidence regarding the effectiveness of plant protein-based microencapsulation technology for probiotic delivery and improve understanding of the impact of targeted probiotic supplementation on intestinal colonisation and the human gut microbiome.
- Conditions
- Colonization, Asymptomatic, Probiotic Intervention, Gut Microbiota Diversity and Composition, Gut-brain Axis
- Being tested
- Microencapsulated Lactobacillus rhamnosus Fruit Snack, Placebo Fruit Snack
- Keywords
- Probiotics, L.rhamnosus, gut microbiome, gastrointestinal health, microencapsulated probiotics
- Medical subject headings
- Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microencapsulated Lactobacillus rhamnosus Fruit SnackDietary supplement
Also called Probiotic fruit snack, Lactobacillus rhamnosus encapsulated 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 SnackDietary supplement
Also called Non-probiotics fruit snack, control 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo Fruit Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period).
Secondary outcomes (6)
Serum serotonin concentration
Serum serotonin levels will be measured from blood samples to assess systemic neuroactive changes.
Measured: 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)
Serum BDNF levels measured as a marker of neurotrophic activity and brain-gut axis signalling.
Measured: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Inflammatory cytokine (IL-6) concentration
Plasma concentrations of IL-6 will be measured as indicators of systemic inflammatory and anti-inflammatory responses.
Measured: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Inflammatory cytokine (IL-10) concentration
Plasma concentrations IL-10 will be measured as indicators of systemic inflammatory and anti-inflammatory responses.
Measured: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Inflammatory cytokine (TNF-alpha)
Plasma concentrations TNF-α will be measured as indicators of systemic inflammatory and anti-inflammatory responses.
Measured: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Intestinal fatty acid-binding protein (I-FABP)
Plasma I-FABP levels will be measured as a marker of intestinal epithelial integrity and permeability.
Measured: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start18 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Colonization, AsymptomaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carel le Roux, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679490
- Sponsor's protocol ID
- RS24-010
- Acronym
- Probiotics
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou JS, Shu Q, Rutherfurd KJ, Prasad J, Gopal PK, Gill HS. Acute oral toxicity and bacterial translocation studies on potentially probiotic strains of lactic acid bacteria. Food Chem Toxicol. 2000 Feb-Mar;38(2-3):153-61. doi: 10.1016/s0278-6915(99)00154-4.
PubMed 10717355Zhou JS, Pillidge CJ, Gopal PK, Gill HS. Antibiotic susceptibility profiles of new probiotic Lactobacillus and Bifidobacterium strains. Int J Food Microbiol. 2005 Feb 1;98(2):211-7. doi: 10.1016/j.ijfoodmicro.2004.05.011.
PubMed 15681048Zahr NM, Mayer D, Pfefferbaum A, Sullivan EV. Low striatal glutamate levels underlie cognitive decline in the elderly: evidence from in vivo molecular spectroscopy. Cereb Cortex. 2008 Oct;18(10):2241-50. doi: 10.1093/cercor/bhm250. Epub 2008 Jan 29.
PubMed 18234683Yao M, Xie J, Du H, McClements DJ, Xiao H, Li L. Progress in microencapsulation of probiotics: A review. Compr Rev Food Sci Food Saf. 2020 Mar;19(2):857-874. doi: 10.1111/1541-4337.12532. Epub 2020 Feb 11.
PubMed 33325164Wu D, Lewis ED, Pae M, Meydani SN. Nutritional Modulation of Immune Function: Analysis of Evidence, Mechanisms, and Clinical Relevance. Front Immunol. 2019 Jan 15;9:3160. doi: 10.3389/fimmu.2018.03160. eCollection 2018.
PubMed 30697214World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714Wickens KL, Barthow CA, Murphy R, Abels PR, Maude RM, Stone PR, Mitchell EA, Stanley TV, Purdie GL, Kang JM, Hood FE, Rowden JL, Barnes PK, Fitzharris PF, Crane J. Early pregnancy probiotic supplementation with Lactobacillus rhamnosus HN001 may reduce the prevalence of gestational diabetes mellitus: a randomised controlled trial. Br J Nutr. 2017 Mar;117(6):804-813. doi: 10.1017/S0007114517000289. Epub 2017 Apr 3.
PubMed 28367765Rode J, Edebol Carlman HMT, Konig J, Repsilber D, Hutchinson AN, Thunberg P, Andersson P, Persson J, Kiselev A, Lathrop Stern L, Salomon B, Mohammed AA, Labus JS, Brummer RJ. Probiotic Mixture Containing Lactobacillus helveticus, Bifidobacterium longum and Lactiplantibacillus plantarum Affects Brain Responses Toward an Emotional Task in Healthy Subjects: A Randomized Clinical Trial. Front Nutr. 2022 Apr 29;9:827182. doi: 10.3389/fnut.2022.827182. eCollection 2022.
PubMed 35571902Moro-Garcia MA, Alonso-Arias R, Baltadjieva M, Fernandez Benitez C, Fernandez Barrial MA, Diaz Ruisanchez E, Alonso Santos R, Alvarez Sanchez M, Saavedra Mijan J, Lopez-Larrea C. Oral supplementation with Lactobacillus delbrueckii subsp. bulgaricus 8481 enhances systemic immunity in elderly subjects. Age (Dordr). 2013 Aug;35(4):1311-26. doi: 10.1007/s11357-012-9434-6. Epub 2012 May 30.
PubMed 22645023Hutchinson AN, Bergh C, Kruger K, Susserova M, Allen J, Ameen S, Tingo L. The Effect of Probiotics on Health Outcomes in the Elderly: A Systematic Review of Randomized, Placebo-Controlled Studies. Microorganisms. 2021 Jun 21;9(6):1344. doi: 10.3390/microorganisms9061344.
PubMed 34205818Stewart DA, Burns JM, Beard K, Dall JL, Lennox IM, Roberts MA, Macfarlane GJ. The roles of general and geriatric medicine in the provision of acute medical care for elderly patients. Health Bull (Edinb). 1992 May;50(3):259-66.
PubMed 1506196Gbassi GK, Vandamme T. Probiotic encapsulation technology: from microencapsulation to release into the gut. Pharmaceutics. 2012 Feb 6;4(1):149-63. doi: 10.3390/pharmaceutics4010149.
PubMed 24300185Costabile A, Bergillos-Meca T, Rasinkangas P, Korpela K, de Vos WM, Gibson GR. Effects of Soluble Corn Fiber Alone or in Synbiotic Combination with Lactobacillus rhamnosus GG and the Pilus-Deficient Derivative GG-PB12 on Fecal Microbiota, Metabolism, and Markers of Immune Function: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Healthy Elderly (Saimes Study). Front Immunol. 2017 Dec 12;8:1443. doi: 10.3389/fimmu.2017.01443. eCollection 2017.
PubMed 29312280Bagga D, Aigner CS, Reichert JL, Cecchetto C, Fischmeister FPS, Holzer P, Moissl-Eichinger C, Schopf V. Influence of 4-week multi-strain probiotic administration on resting-state functional connectivity in healthy volunteers. Eur J Nutr. 2019 Aug;58(5):1821-1827. doi: 10.1007/s00394-018-1732-z. Epub 2018 May 30.
PubMed 29850990Anderson LA, Goodman RA, Holtzman D, Posner SF, Northridge ME. Aging in the United States: opportunities and challenges for public health. Am J Public Health. 2012 Mar;102(3):393-5. doi: 10.2105/AJPH.2011.300617. Epub 2012 Jan 19. No abstract available.
PubMed 22390500
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Study of a Fruit Snack Containing Probiotics
- ClinicalTrials.gov ID
- NCT07679490
- Acronym / sponsor ID
- Probiotics / RS24-010
- Conditions
- Colonization, Asymptomatic, Probiotic Intervention, Gut Microbiota Diversity and Composition, Gut-brain Axis
- Keywords
- Probiotics, L.rhamnosus, gut microbiome, gastrointestinal health, microencapsulated probiotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
The gut microbiota plays an important role in human health through interactions with the gastrointestinal, immune, endocrine, and nervous systems. Increasing evidence suggests that the gut microbiota influences gastrointestinal and brain function through the microbiota-gut-brain axis, a bidirectional communication network linking the gastrointestinal tract and the central nervous system. Alterations in gut microbial composition have been associated with aging-related physiological changes, gastrointestinal function, inflammation, cognition, and mood.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. However, the effectiveness of probiotic supplementation depends on the ability of viable microorganisms to survive food processing, storage, gastric acidity, and gastrointestinal transit before reaching their target site in the intestine. Consequently, strategies that improve probiotic survival and targeted delivery may enhance intestinal colonisation and biological activity within the gastrointestinal tract.
Microencapsulation is a promising approach for protecting probiotic bacteria during manufacturing, storage, and passage through the upper gastrointestinal tract. Encapsulation within a protective plant protein matrix may increase delivery of viable probiotic cells to the intestine by reducing exposure to gastric acid and digestive enzymes. The investigational product used in this study contains Lactobacillus rhamnosus microencapsulated using a plant protein-based delivery system and incorporated into a fruit snack.
The primary objective of this study is to determine whether daily consumption of a fruit snack containing microencapsulated Lactobacillus rhamnosus increases intestinal colonisation compared with a matched fruit snack without probiotics. Colonisation will be assessed by measuring the abundance of Lactobacillus rhamnosus in stool samples.
Secondary objectives include evaluating the effects of the intervention on gut microbiome composition and diversity, and exploring changes in markers related to gastrointestinal function and microbiota-gut-brain axis physiology.
This study is a randomised, double-blind, placebo-controlled crossover trial. Participants will complete two 28-day intervention periods separated by a 14-day washout period. Participants will receive both study interventions in a random order: (1) a fruit snack containing microencapsulated Lactobacillus rhamnosus and (2) a matched fruit snack without probiotics.
Participants will consume one 28-g serving of the assigned fruit snack each day during each intervention period. The probiotic snack contains Lactobacillus rhamnosus at a concentration of 2 × 10⁹ colony-forming units (CFU) per gram, providing a total daily dose of approximately 5.6 × 10¹⁰ CFU (56 billion CFU/day). Stool samples will be collected at predefined study visits to assess probiotic colonisation and changes in gut microbiome composition.
This study will provide evidence regarding the effectiveness of plant protein-based microencapsulation technology for probiotic delivery and improve understanding of the impact of targeted probiotic supplementation on intestinal colonisation and the human gut microbiome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1 | Active comparator | Dietary Supplement: Microencapsulated Lactobacillus rhamnosus Fruit SnackParticipants 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. |
| Experimental Arm 2 | Placebo comparator | Dietary Supplement: Placebo Fruit SnackParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microencapsulated Lactobacillus rhamnosus Fruit SnackAlso: Probiotic fruit snack, Lactobacillus rhamnosus encapsulated snackParticipants 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. | Dietary supplement | Experimental Arm 1 |
| Placebo Fruit SnackAlso: Non-probiotics fruit snack, control fruit snackParticipants 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. | Dietary supplement | Experimental Arm 2 |
Primary outcome
Change in faecal abundance of Lactobacillus rhamnosus
Time frame: 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.
6 secondary outcomes
Serum serotonin concentration
Time frame: 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)
Time frame: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Inflammatory cytokine (IL-6) concentration
Time frame: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Inflammatory cytokine (IL-10) concentration
Time frame: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Inflammatory cytokine (TNF-alpha)
Time frame: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Intestinal fatty acid-binding protein (I-FABP)
Time frame: Baseline, end of Period 1 (Day 28), end of washout (Day 42), and end of Period 2 (Day 70)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 10717355Zhou JS, Shu Q, Rutherfurd KJ, Prasad J, Gopal PK, Gill HS. Acute oral toxicity and bacterial translocation studies on potentially probiotic strains of lactic acid bacteria. Food Chem Toxicol. 2000 Feb-Mar;38(2-3):153-61. doi: 10.1016/s0278-6915(99)00154-4.
- Background: PubMed 15681048Zhou JS, Pillidge CJ, Gopal PK, Gill HS. Antibiotic susceptibility profiles of new probiotic Lactobacillus and Bifidobacterium strains. Int J Food Microbiol. 2005 Feb 1;98(2):211-7. doi: 10.1016/j.ijfoodmicro.2004.05.011.
- Background: PubMed 18234683Zahr NM, Mayer D, Pfefferbaum A, Sullivan EV. Low striatal glutamate levels underlie cognitive decline in the elderly: evidence from in vivo molecular spectroscopy. Cereb Cortex. 2008 Oct;18(10):2241-50. doi: 10.1093/cercor/bhm250. Epub 2008 Jan 29.
- Background: PubMed 33325164Yao M, Xie J, Du H, McClements DJ, Xiao H, Li L. Progress in microencapsulation of probiotics: A review. Compr Rev Food Sci Food Saf. 2020 Mar;19(2):857-874. doi: 10.1111/1541-4337.12532. Epub 2020 Feb 11.
- Background: PubMed 30697214Wu D, Lewis ED, Pae M, Meydani SN. Nutritional Modulation of Immune Function: Analysis of Evidence, Mechanisms, and Clinical Relevance. Front Immunol. 2019 Jan 15;9:3160. doi: 10.3389/fimmu.2018.03160. eCollection 2018.
- Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
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- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microencapsulated Lactobacillus rhamnosus Fruit Snack in people with Colonization, Asymptomatic and Probiotic Intervention, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in faecal abundance of Lactobacillus rhamnosus (time frame: Baseline, Day 28, Day 42 (end of washout), Day 70 (end of second intervention period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07679490, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.