NCT07439978

Encapsulated Probiotics & Gut Microbiota

A Physiological Study of a Fermented Yogurt Drink Containing Probiotics

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to 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. Fifty participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the blood and faecal effects 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. The current study will provide important information on the physiological function of probiotics in the small bowel. 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 plan to assess the gut microbiome and changes in probiotic 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 1 billion 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. The current study will provide important information on the physiological function of probiotics in metabolic and inflammatory biochemical parameters, as well as in their capacity to colonise the gastrointestinal tract.

Conditions

• Colonization, Asymptomatic
• Colonisation

Interventions

Type	Name	Description
BIOLOGICAL	probiotic containing L.rhamnosus R0011 strain	Fifty 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 1Billion 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	Fifty 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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2026-02-27
• Last updated: 2026-02-27