Less Than 3 Months Old, Healthy Infants
Conditions
Keywords
Gut microbiome, Oral probiotics, Healthy infants
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.
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 1. To evaluate the impact of supplementation infant growth. Growth will be monitored by recording infant weight, length, and head circumference following the probiotic intervention. 2. To evaluate the safety of the probiotics and the incidence rate of allergies and abdominal disturbances (eczema, skin itching, bloating/abdominal distension, diarrhoea). 3. 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. 4. To detect the levels of short-chain fatty acids (SCFAs) in the faecal samples following the probiotic intervention.
Interventions
DIETARY_SUPPLEMENTPlacebo (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_SUPPLEMENTProbiotic
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.
Sponsors
University College Cork
APC Microbiome Ireland, UCC
Irish Centre for Fetal and Neonatal Translational Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure - Infant length | 18 months | To evaluate the impact of supplementation infant length. Length will be monitored by recording infant length (in cm) following the probiotic intervention. |
| Secondary Outcome Measure - Infant Weight | 18 months | To evaluate the impact of supplementation infant weight. Weight will be monitored by recording infant weight (in kg) following the probiotic intervention. |
| Secondary Outcome Measure - Head circumference | 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. |
| Secondary Outcome Measure - SCFA Analysis | 18 months | To detect the levels of short-chain fatty acids (SCFAs) in the faecal samples following the probiotic intervention. |
| Secondary Outcome Measure - Peptide Analysis (HBD-2) | 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. |
| Secondary Outcome Measure - Peptide Analysis (LL-37) | 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. |
| Secondary Outcome Measure - Food Allergy Assessment (Eczema) | 18 months | To evaluate the safety of the probiotics and the incidence rate of skin allergies (eczema). |
| Secondary Outcome Measure - Food Allergy Assessment (Diarrhea) | 18 months | To evaluate the safety of the probiotics and the incidence rate of abdominal disturbances such as diarrheal episodes. |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATOREugene M Dempsey, FRCPI
University College Cork
Outcome results
None listed