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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
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
Conditions
Interventions
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.
Locations (1)
University College Cork
Cork, Ireland