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 | Not Yet Recruiting

• 1 other identifier: APC198
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Less Than 3 Months Old; Healthy Infants

Keywords

Gut microbiome; Oral probiotics; Healthy infants

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  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.

  18 months

Secondary Outcomes (8)

• Secondary Outcome Measure - Infant length

  18 months

• Secondary Outcome Measure - Infant Weight

  18 months

• Secondary Outcome Measure - Head circumference

  18 months

• Secondary Outcome Measure - SCFA Analysis

  18 months

• Secondary Outcome Measure - Peptide Analysis (HBD-2)

  18 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo (maltodextrin)

Probiotic 1

EXPERIMENTAL

BLa80

Dietary Supplement: Probiotic

Probiotic 2

EXPERIMENTAL

LRa05

Dietary Supplement: Probiotic

Interventions

Placebo (maltodextrin) DIETARY_SUPPLEMENT

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.

Placebo

Probiotic DIETARY_SUPPLEMENT

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 1

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead
• APC Microbiome Ireland, UCC: collaborator
• Irish Centre for Fetal and Neonatal Translational Research: collaborator

Study Sites (1)

University College Cork

Cork, Ireland

Location

Related Publications (4)

• Wu T, Zhang Y, Li W, Zhao Y, Long H, Muhindo EM, Liu R, Sui W, Li Q, Zhang M. Lactobacillus rhamnosus LRa05 Ameliorate Hyperglycemia through a Regulating Glucagon-Mediated Signaling Pathway and Gut Microbiota in Type 2 Diabetic Mice. J Agric Food Chem. 2021 Aug 11;69(31):8797-8806. doi: 10.1021/acs.jafc.1c02925. Epub 2021 Aug 2.

  PMID: 34340304 BACKGROUND

• Niu Y, Li J, Qian H, Liang C, Shi X, Bu S. Evaluation of efficacy and safety of Lacticaseibacillus rhamnosus LRa05 in the eradication of Helicobacter pylori: a randomized, double-blind, placebo-controlled trial. Front Immunol. 2024 Aug 21;15:1450414. doi: 10.3389/fimmu.2024.1450414. eCollection 2024.

  PMID: 39234246 BACKGROUND

• Chen K, Zeng K, Jin S, Ma Y, Cai L, Xu P, Nie Y, Luo L, Yu Q, Liu C. Lacticaseibacillus rhamnosus LRa05 in the treatment of acute diarrhea in children: a randomized controlled trial. Front Nutr. 2024 Nov 15;11:1479186. doi: 10.3389/fnut.2024.1479186. eCollection 2024.

  PMID: 39619284 BACKGROUND

• Chen K, Jin S, Ma Y, Cai L, Xu P, Nie Y, Luo L, Yu Q, Shen Y, Zhou Z, Liu C. Adjudicative efficacy of Bifidobacterium animalis subsp. lactis BLa80 in treating acute diarrhea in children: a randomized, double-blinded, placebo-controlled study. Eur J Clin Nutr. 2024 Jun;78(6):501-508. doi: 10.1038/s41430-024-01428-6. Epub 2024 Mar 11.

  PMID: 38467857 BACKGROUND

MeSH Terms

Interventions

maltodextrin; Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eugene M Dempsey, FRCPI

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The total number of infants required to complete this study is 240 (three arms with 80 infants per arm), and considering 20% drop-out rate, we will aim to recruit 100 infants per arm, so in total we aim to recruit \~ approx. 300 subjects under the age of 3 months, to have a final number of 240 subjects enrolled to the end of the study, when the infants are at most, 6 months old. Recruitment will be conducted over an 18-month period. Parents of eligible infants will be approached in CUMH for enrollment onto the study. This is a randomized controlled trial (RCT) study design, in which healthy infants will be randomly assigned to one of the 3 arms, either probiotic (BLa80 or LRa05) or placebo (maltodextrin) N = 80/group for 12 weeks.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: April 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IE (1)