Less Than 3 Months OldSMILENCT07505329
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.
A study testing Probiotic in people with Less Than 3 Months Old and Healthy Infants, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Less Than 3 Months Old, Healthy Infants
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site
University College Cork
Cork
Eugene M Dempsey, FRCPI, +353 214920525, gene.dempsey@hse.ie
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Less Than 3 Months Old, Healthy Infants
- Being tested
- Placebo (maltodextrin), Probiotic
- Keywords
- Gut microbiome, Oral probiotics, Healthy infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ProbioticDietary 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.
ProbioticDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo (maltodextrin) |
| Probiotic 1 | Experimental | BLa80 Receives: Dietary Supplement: Probiotic |
| Probiotic 2 | Experimental | LRa05 Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (8)
Secondary Outcome Measure - Infant length
To evaluate the impact of supplementation infant length. Length will be monitored by recording infant length (in cm) following the probiotic intervention.
Measured: 18 months
Secondary Outcome Measure - Infant Weight
To evaluate the impact of supplementation infant weight. Weight will be monitored by recording infant weight (in kg) following the probiotic intervention.
Measured: 18 months
Secondary Outcome Measure - Head circumference
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.
Measured: 18 months
Secondary Outcome Measure - SCFA Analysis
To detect the levels of short-chain fatty acids (SCFAs) in the faecal samples following the probiotic intervention.
Measured: 18 months
Secondary Outcome Measure - Peptide Analysis (HBD-2)
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.
Measured: 18 months
Secondary Outcome Measure - Peptide Analysis (LL-37)
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.
Measured: 18 months
Secondary Outcome Measure - Food Allergy Assessment (Eczema)
To evaluate the safety of the probiotics and the incidence rate of skin allergies (eczema).
Measured: 18 months
Secondary Outcome Measure - Food Allergy Assessment (Diarrhea)
To evaluate the safety of the probiotics and the incidence rate of abdominal disturbances such as diarrheal episodes.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Less Than 3 Months OldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- APC Microbiome Ireland, UCC, Irish Centre for Fetal and Neonatal Translational Research
- Responsible party
- Principal investigator, Gene Dempsey, University College Cork
- Investigators
- Eugene M Dempsey, FRCPI, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505329
- Sponsor's protocol ID
- APC198
- Acronym
- SMILE
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34340304Niu 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.
PubMed 39234246Chen 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.
PubMed 39619284Chen 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.
PubMed 38467857
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07505329
- Acronym / sponsor ID
- SMILE / APC198
- Conditions
- Less Than 3 Months Old, Healthy Infants
- Keywords
- Gut microbiome, Oral probiotics, Healthy infants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- APC Microbiome Ireland, UCC, Irish Centre for Fetal and Neonatal Translational Research
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)Maltodextrin |
| Probiotic 1 | Experimental | Dietary Supplement: ProbioticBLa80 |
| Probiotic 2 | Experimental | Dietary Supplement: ProbioticLRa05 |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Placebo |
| ProbioticThis 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 1 |
| ProbioticThis 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. | Dietary supplement | Probiotic 2 |
Primary outcome
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.
8 secondary outcomes
Secondary Outcome Measure - Infant length
Time frame: 18 months
Secondary Outcome Measure - Infant Weight
Time frame: 18 months
Secondary Outcome Measure - Head circumference
Time frame: 18 months
Secondary Outcome Measure - SCFA Analysis
Time frame: 18 months
Secondary Outcome Measure - Peptide Analysis (HBD-2)
Time frame: 18 months
Secondary Outcome Measure - Peptide Analysis (LL-37)
Time frame: 18 months
Secondary Outcome Measure - Food Allergy Assessment (Eczema)
Time frame: 18 months
Secondary Outcome Measure - Food Allergy Assessment (Diarrhea)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 34340304Wu 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.
- Background: PubMed 39234246Niu 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.
- Background: PubMed 39619284Chen 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.
- Background: PubMed 38467857Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugene M Dempsey, FRCPI principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Less Than 3 Months Old and Healthy Infants, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07505329, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.