Colonization, AsymptomaticPhase 1ProbioticNCT07510282
Probiotic Delivered to the Small Intestine Changes Microbiota
A Phase 1 study testing Probiotic containing L.rhamnosus R0011 strain and 200 ml yogurt drink in people with Colonization, Asymptomatic and Colonization, run by University College Dublin.
Trial summary
This study will determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function. 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, Colonization
- What is being tested?
- Probiotic containing L.rhamnosus R0011 strain and 200 ml yogurt drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to Dec 2026
- Phase
- Phase 1
- 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
- Capacity to obtain and sign informed consent before any study-related procedure
- 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
- Diagnosis of type 1 and/or type 2 diabetes
- Current (or within the last 4 weeks prior to the study start) use of probiotic supplementation.
- Immobile (defined as the inability to participate in all study-related procedures)
Show all 18Show fewer
- History of complicated gastrointestinal surgery
- Diagnosed with 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 principal 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Physiological Study on How Probiotic Delivered to the Small Intestine Changes Microbiota
This study will determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function. Participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the effects of the blood chemicals and bacterial composition in faeces of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+/13 days. This study will provide important information regarding the physiological function of probiotics in the small intestine. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.
Read the detailed description
The investigators will assess the gut microbiome and changes in its diversity at the end of a course of a beverage containing encapsulated Lacticaseibacillus rhamnosus, compared to those at the end of a course of the same beverage without probiotics.This is a randomised, double-blinded, placebo-controlled crossover study. Fifty healthy men and women with a body mass index (BMI) between 18.5-31.9 kg/m2, aged 25-65 years, will be recruited and randomised to a commercial fermented (yoghurt) drink containing a) encapsulated probiotics consisting of Lacticaseibacillus rhamnosus, or b) a non-probiotic fermented (yoghurt) dairy drink (control). The number of participants includes a 10% drop-out rate.Each participant will be studied on four occasions in random order following a crossover design. Each will receive a 200 ml beverage containing yoghurt per day for 28 days, either a) fortified with 2x109 CFU (6BN) probiotics contained in pea protein capsules or b) the control beverage (same yoghurt without probiotic). Faecal samples will be collected on four occasions: at baseline, and at 28, 42 and 70 days after baseline. This study will provide important information on the physiological function of probiotics in metabolic and inflammatory regulation, as well as in their capacity to colonise the gastrointestinal tract.
- Conditions
- Colonization, Asymptomatic, Colonization
- Being tested
- Probiotic containing L.rhamnosus R0011 strain, 200 ml yogurt drink
- Keywords
- Probiotic, Microbiota, Colonization, Dairy
- Medical subject headings
- Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic containing L.rhamnosus R0011 strainBiological
Tewnty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose of 200 ml on two different occasions for 28 days, a commercial dairy drink fortified with with 2x109 CFU (6BN) probiotics in the pea protein capsules. Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline.
200 ml yogurt drinkDietary supplement
Twenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline
| Study group | Role | What they receive |
|---|---|---|
| Probiotic drink | Experimental | Twenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose of 200 ml on two different occasions for 28 days, a commercial dairy drink fortified with 2x109 CFU (6BN) probiotics in the pea protein capsules. Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline Receives: Biological: Probiotic containing L.rhamnosus R0011 strain |
| Placebo drink | Active comparator | Twenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline Receives: Dietary Supplement: 200 ml yogurt drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization
Faecal abundance of Lactobacillus rhamnosus after probiotic consumption measured through shotgun metagenomics -libraries with Illumina Nextera XT, sequenced 150 bp paired-end on NextSeq 2000. Negative + positive controls will be processed alongside study samples with around 15M paired reads/sample after quality controls.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each individual will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, either a) in a commercial dairy drink fortified with 2x109 CFU (6BN) probiotics in pea protein capsules or b) a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days, 42 days and 70 days after baseline.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carel Le Roux, PhD, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510282
- Sponsor's protocol ID
- RS24-063
- Acronym
- Probiotic
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will be carried out in a single center. Therefore, fecal samples sent for microbiota analysis and data for statistical analyses will be identified by numbers allocated in the protocol and not contain identifiable information.
Publications
Bagga 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 29850990Betzel RF, Byrge L, He Y, Goni J, Zuo XN, Sporns O. Changes in structural and functional connectivity among resting-state networks across the human lifespan. Neuroimage. 2014 Nov 15;102 Pt 2:345-57. doi: 10.1016/j.neuroimage.2014.07.067. Epub 2014 Aug 7.
PubMed 25109530Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Anderson 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 22390500Christensen SE, Moller E, Bonn SE, Ploner A, Wright A, Sjolander A, Balter O, Lissner L, Balter K. Two new meal- and web-based interactive food frequency questionnaires: validation of energy and macronutrient intake. J Med Internet Res. 2013 Jun 5;15(6):e109. doi: 10.2196/jmir.2458.
PubMed 23739995Costabile 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 29312280Gill HS, Rutherfurd KJ, Cross ML. Dietary probiotic supplementation enhances natural killer cell activity in the elderly: an investigation of age-related immunological changes. J Clin Immunol. 2001 Jul;21(4):264-71. doi: 10.1023/a:1010979225018.
PubMed 11506196Halverson T, Alagiakrishnan K. Gut microbes in neurocognitive and mental health disorders. Ann Med. 2020 Dec;52(8):423-443. doi: 10.1080/07853890.2020.1808239. Epub 2020 Aug 31.
PubMed 32772900Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
PubMed 24912386Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.
PubMed 22797518Gbassi 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 24300185Hutchinson 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 34205818Moro-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 22645023Rode 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 35571902Wickens 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 28367765
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Study on How Probiotic Delivered to the Small Intestine Changes Microbiota
- ClinicalTrials.gov ID
- NCT07510282
- Acronym / sponsor ID
- Probiotic / RS24-063
- Conditions
- Colonization, Asymptomatic, Colonization
- Keywords
- Probiotic, Microbiota, Colonization, Dairy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Apr 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.
This study will determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function. Participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the effects of the blood chemicals and bacterial composition in faeces of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+/13 days. This study will provide important information regarding the physiological function of probiotics in the small intestine. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.
Detailed description
The investigators will assess the gut microbiome and changes in its diversity at the end of a course of a beverage containing encapsulated Lacticaseibacillus rhamnosus, compared to those at the end of a course of the same beverage without probiotics.This is a randomised, double-blinded, placebo-controlled crossover study. Fifty healthy men and women with a body mass index (BMI) between 18.5-31.9 kg/m2, aged 25-65 years, will be recruited and randomised to a commercial fermented (yoghurt) drink containing a) encapsulated probiotics consisting of Lacticaseibacillus rhamnosus, or b) a non-probiotic fermented (yoghurt) dairy drink (control). The number of participants includes a 10% drop-out rate.Each participant will be studied on four occasions in random order following a crossover design. Each will receive a 200 ml beverage containing yoghurt per day for 28 days, either a) fortified with 2x109 CFU (6BN) probiotics contained in pea protein capsules or b) the control beverage (same yoghurt without probiotic). Faecal samples will be collected on four occasions: at baseline, and at 28, 42 and 70 days after baseline. This study will provide important information on the physiological function of probiotics in metabolic and inflammatory regulation, as well as in their capacity to colonise the gastrointestinal tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each individual will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, either a) in a commercial dairy drink fortified with 2x109 CFU (6BN) probiotics in pea protein capsules or b) a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days, 42 days and 70 days after baseline.
| Arm | Type | Receives |
|---|---|---|
| Probiotic drink | Experimental | Biological: Probiotic containing L.rhamnosus R0011 strainTwenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose of 200 ml on two different occasions for 28 days, a commercial dairy drink fortified with 2x109 CFU (6BN) probiotics in the pea protein capsules. Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline |
| Placebo drink | Active comparator | Dietary Supplement: 200 ml yogurt drinkTwenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Capacity to obtain and sign informed consent before any study-related procedure
- 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 (18 listed)
- Smoking
- Substance abuse
- Pregnancy
- Diagnosis of type 1 and/or type 2 diabetes
- Current (or within the last 4 weeks prior to the 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 |
|---|---|---|
| Probiotic containing L.rhamnosus R0011 strainTewnty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose of 200 ml on two different occasions for 28 days, a commercial dairy drink fortified with with 2x109 CFU (6BN) probiotics in the pea protein capsules. Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline. | Biological | Probiotic drink |
| 200 ml yogurt drinkTwenty-five participants will be studied on four occasions in random order and in a crossover design. Subjects will receive a daily dose 200 ml on two different occasions for 28 days, a commercial dairy drink (no probiotics). Feacal samples will be collected on four occasions: at baseline, 28 days after baseline, 42 days and 70 days after baseline | Dietary supplement | Placebo drink |
Primary outcome
Colonization
Time frame: 28 days
Faecal abundance of Lactobacillus rhamnosus after probiotic consumption measured through shotgun metagenomics -libraries with Illumina Nextera XT, sequenced 150 bp paired-end on NextSeq 2000. Negative + positive controls will be processed alongside study samples with around 15M paired reads/sample after quality controls.
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 3 Apr 2026.
- Background: PubMed 29850990Bagga 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.
- Background: PubMed 25109530Betzel RF, Byrge L, He Y, Goni J, Zuo XN, Sporns O. Changes in structural and functional connectivity among resting-state networks across the human lifespan. Neuroimage. 2014 Nov 15;102 Pt 2:345-57. doi: 10.1016/j.neuroimage.2014.07.067. Epub 2014 Aug 7.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Background: PubMed 22390500Anderson 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.
- Background: PubMed 23739995Christensen SE, Moller E, Bonn SE, Ploner A, Wright A, Sjolander A, Balter O, Lissner L, Balter K. Two new meal- and web-based interactive food frequency questionnaires: validation of energy and macronutrient intake. J Med Internet Res. 2013 Jun 5;15(6):e109. doi: 10.2196/jmir.2458.
- Background: PubMed 29312280Costabile 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.
- Background: PubMed 11506196Gill HS, Rutherfurd KJ, Cross ML. Dietary probiotic supplementation enhances natural killer cell activity in the elderly: an investigation of age-related immunological changes. J Clin Immunol. 2001 Jul;21(4):264-71. doi: 10.1023/a:1010979225018.
- Background: PubMed 32772900Halverson T, Alagiakrishnan K. Gut microbes in neurocognitive and mental health disorders. Ann Med. 2020 Dec;52(8):423-443. doi: 10.1080/07853890.2020.1808239. Epub 2020 Aug 31.
- Background: PubMed 24912386Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
- Background: PubMed 22797518Claesson MJ, Jeffery IB, Conde S, Power SE, O'Connor EM, Cusack S, Harris HM, Coakley M, Lakshminarayanan B, O'Sullivan O, Fitzgerald GF, Deane J, O'Connor M, Harnedy N, O'Connor K, O'Mahony D, van Sinderen D, Wallace M, Brennan L, Stanton C, Marchesi JR, Fitzgerald AP, Shanahan F, Hill C, Ross RP, O'Toole PW. Gut microbiota composition correlates with diet and health in the elderly. Nature. 2012 Aug 9;488(7410):178-84. doi: 10.1038/nature11319.
- Background: PubMed 24300185Gbassi 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.
- Background: PubMed 34205818Hutchinson 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.
- Individual participant dataSharing planned: No. This study will be carried out in a single center. Therefore, fecal samples sent for microbiota analysis and data for statistical analyses will be identified by numbers allocated in the protocol and not contain identifiable information.
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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.
Carel Le Roux, PhD principal investigator
St Vincent's University Hospital, Ireland
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotic containing L.rhamnosus R0011 strain and 200 ml yogurt drink in people with Colonization, Asymptomatic and Colonization, run by University College Dublin.
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 18 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ahmed Al-Humadi, PhD (+353 083 0994008, ahmed.al-humadi@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonization (time frame: 28 days). 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 NCT07510282, which also lists 23 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 3 Apr 2026.