Encapsulated Probiotics & Gut Microbiota

NCT07439978 | Not Yet Recruiting Phase 1

• 1 other identifier: REF No. RS26-013
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. Twenty-five 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.

Conditions

Colonization, Asymptomatic; Colonisation

Keywords

Probiotic; Microbiota; Colonization; Dairy

Outcome Measures

Primary Outcomes (1)

• Colonisation

  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.

  28 days

Study Arms (2)

Probiotic drink

EXPERIMENTAL

Encapsulated Lacticaseibacillus rhamnosus in 200 ml Yogurt drink

Biological: probiotic containing L.rhamnosus R0011 strain

Placebo drink

PLACEBO COMPARATOR

200 ml yogurt drink

Dietary Supplement: 200 ml yogurt drink

Interventions

probiotic containing L.rhamnosus R0011 strain BIOLOGICAL

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 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.

Probiotic drink

200 ml yogurt drink DIETARY_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.

Placebo drink

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded:
• Smoking
• Substance abuse
• Pregnancy
• 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)
• History of complicated gastrointestinal surgery
• Diagnosed with inflammatory bowel disease (IBD)
• Current diagnosis of psychiatric disease/s or syndromes
• Current diagnosis of neurodegenerative disease
• 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

Sponsors & Collaborators

• University College Dublin: lead

Related Publications (23)

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MeSH Terms

Conditions

Asymptomatic Infections

Condition Hierarchy (Ancestors)

Infections; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carel Le Roux, PhD

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Werd Al-Najim, PhD

CONTACT

+353 0864117842; werd.al-najim@ucd.ie

Ahmed Al-Humadi, PhD

CONTACT

+353 083 0994008; ahmed.al-humadi@ucd.ie

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject 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 1Billion 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.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: August 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share