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NOT YET RECRUITING

NCT07510282

PHASE1

Probiotic Delivered to the Small Intestine Changes Microbiota

Sponsor: University College Dublin

View on ClinicalTrials.gov

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. 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.

Official title: A Physiological Study on How Probiotic Delivered to the Small Intestine Changes Microbiota

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-15

Completion Date

2026-12

Last Updated

2026-04-03

Healthy Volunteers

Yes

Conditions

Colonization, Asymptomatic Colonization

Interventions

BIOLOGICAL

Probiotic containing L.rhamnosus R0011 strain

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.

DIETARY_SUPPLEMENT

200 ml yogurt drink

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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) * 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.