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NCT Number: NCT07505329

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.

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.

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Key information

Conditions

Less Than 3 Months Old Healthy Infants

Age range

1 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Secondary Objectives

  • To evaluate the impact of supplementation infant growth. Growth will be monitored by recording infant weight, length, and head circumference following the probiotic intervention.
  • To evaluate the safety of the probiotics and the incidence rate of allergies and abdominal disturbances (eczema, skin itching, bloating/abdominal distension, diarrhoea).
  • To detect human beta-defensin 2 (HBD-2) and Human Antimicrobial Peptide LL-37 (LL-37) in the faecal samples which aims to evaluate the impact of the two probiotic strains on the immune health of the infants following the probiotic intervention.
  • To detect the levels of short-chain fatty acids (SCFAs) in the faecal samples following the probiotic intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary Objective

    Time frame: 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.

Secondary outcomes

  1. Secondary Outcome Measure - Infant length

    Time frame: 18 months

    To evaluate the impact of supplementation infant length. Length will be monitored by recording infant length (in cm) following the probiotic intervention.

  2. Secondary Outcome Measure - Infant Weight

    Time frame: 18 months

    To evaluate the impact of supplementation infant weight. Weight will be monitored by recording infant weight (in kg) following the probiotic intervention.

  3. Secondary Outcome Measure - Head circumference

    Time frame: 18 months

    To evaluate the impact of supplementation infant head circumference. Head circumference will be monitored by recording infant head circumference (in cm) following the probiotic intervention.

  4. Secondary Outcome Measure - SCFA Analysis

    Time frame: 18 months

    To detect the levels of short-chain fatty acids (SCFAs) in the faecal samples following the probiotic intervention.

  5. Secondary Outcome Measure - Peptide Analysis (HBD-2)

    Time frame: 18 months

    To detect human beta-defensin 2 (HBD-2) in the faecal samples which aims to evaluate the impact of the two probiotic strains on the immune health of the infants following the probiotic intervention.

  6. Secondary Outcome Measure - Peptide Analysis (LL-37)

    Time frame: 18 months

    To detect Human Antimicrobial Peptide LL-37 (LL-37) in the faecal samples which aims to evaluate the impact of the two probiotic strains on the immune health of the infants following the probiotic intervention.

  7. Secondary Outcome Measure - Food Allergy Assessment (Eczema)

    Time frame: 18 months

    To evaluate the safety of the probiotics and the incidence rate of skin allergies (eczema).

  8. Secondary Outcome Measure - Food Allergy Assessment (Diarrhea)

    Time frame: 18 months

    To evaluate the safety of the probiotics and the incidence rate of abdominal disturbances such as diarrheal episodes.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • APC Microbiome Ireland, UCC
  • Irish Centre for Fetal and Neonatal Translational Research

Registry information

Acronym: SMILE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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