An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.

NCT07505329 · tracked via the Priya Life Science Ireland tracker

Sponsor

University College Cork

Phase

Not applicable

Started

2026-04

Last updated

2026-04-01

Condition(s) studied

Less Than 3 Months OldHealthy Infants

Investigational drug(s) / intervention(s)

Placebo (maltodextrin)ProbioticProbiotic

Placebo (maltodextrin): This study will investigate the effects of probiotics (Bifidobacterium animalis subsp. lactis BLa80 or Lacticaseibacillus rhamnosus LRa05), versus a placebo (maltodextrin), on the growth of infants and the development of their gut microbiota. The primary focus is on infant growth and gut microbiota development in infants aged 0-6 months. Maltodextrin is white, powdery, almost flavourless starch that is used to mimic the probiotic powder.

Probiotic: This study will investigate the effects of probiotics Bifidobacterium animalis subsp. lactis BLa80, versus a placebo (maltodextrin), on the growth of infants and the development of their gut microbiota. The primary focus is on infant growth and gut microbiota development in infants aged 0-6 months.

Probiotic: This study will investigate the effects of probiotic Lacticaseibacillus rhamnosus LRa05, versus a placebo (maltodextrin), on the growth of infants and the development of their gut microbiota. The primary focus is on infant growth and gut microbiota development in infants aged 0-6 months.

Study summary

The probiotics Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 have potential to enhance infant health and development based on previous research conducted on human infants.

Bifidobacterium animalis subsp. lactis BLa80 was isolated from healthy breast milk samples.

Ten clinical studies have been conducted using this strain, including randomized, double-blind, placebo-controlled trials, involving over 700 clinical subjects, adults and children. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of constipation, improved sleep quality, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, gestational diabetes management and emotional management.

Lacticaseibacillus rhamnosus LRa05 was isolated from healthy baby faeces. Six clinical studies have been conducted, involving randomized, double-blind, placebo-controlled studies using this strain, involving over 500 clinical subjects. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of eczema, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, and gestational diabetes management.

This proposal describes a three-year collaboration with APC Microbiome Ireland, INFANT Research Centre and WeCare to conduct clinical studies to investigate the effects of probiotics (Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa050), compared to a placebo, on the growth of infants and toddlers and the development of their gut microbiota. The focus of this study is on infant growth and gut microbiota development in infants up to 6 months old.

Eligibility

Sex

ALL

Min age

1 Month

Max age

3 Months

Healthy volunteers

Accepted

Inclusion criteria Written (electronic) informed consent provided by parent to allow their infant to participate in the study. No antibiotic use since birth. Infant not to be taking any medications. Infant not to be taking probiotics. Breastfed or formula fed until weaning. Infants born via c-section or vaginally. Healthy male and female infants. Exclusion criteria Infant is older than 3 months at the time their first study visit (Baseline visit). Infants who have a known diagnosis of inflammatory bowel disease or another medical condition. Infants with complex medical or behavioural needs that would deem the infant unable to participate in the study. Have a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates entry to the study according to the investigator's judgement. Infants who are receiving treatment involving experimental medications. Have a malignant disease or any concomitant end-stage organ disease. Infants born before 37 weeks of pregnancy.

Primary outcome measure(s)

Primary Objective — 18 months
The primary aim is to describe the impact of supplementation with the probiotics LRa05 and BLa80 on the developing gut microbiota in infants aged 0-6 months. Gut microbiota structure will be analyzed following shotgun sequencing, including strain presence and persistence in the infant's gut during 0-6 months of age.

Trial sites (1)

Facility	City	Region	Status
University College Cork	Cork	Ireland

More University College Cork trials in Ireland

Generating Intervals of Reference FFor Early Life Brain Biomarkers. Recruiting

AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis Recruiting

Early Detection & Intervention of Cerebral Palsy in Ireland Recruiting

A Probiotic Strategy for Antipsychotic-induced Metabolic Dysfunction Recruiting

Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07505329 on ClinicalTrials.gov ↗ ← All trials in Ireland