Probiotic Delivered to the Small Intestine Changes Microbiota
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-65
SponsorUniversity College Dublin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Smoking
Substance abuse
Pregnancy
Diagnosis of type 1 and/or type 2 diabetes
Trial design
Design model
Crossover
Treatments tested in this trial
Probiotic containing L.rhamnosus R0011 strain
Biological/VaccineTewnty-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 drink
Dietary supplementTwenty-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
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Probiotic drinkExperimental treatment 1 intervention
Group B: Placebo drinkActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
28 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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