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NOT YET RECRUITING
NCT07505329
NA

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.

Sponsor: University College Cork

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Month - 3 Months

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-04

Completion Date

2028-03

Last Updated

2026-04-01

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Locations (1)

University College Cork

Cork, Ireland