Healthy Infants
Conditions
Keywords
Infant, Gastrointestinal Microbiome, Diet, Food, and Nutrition
Brief summary
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
Interventions
OTHERProbiotic
Given daily from 14 days of age until 9 months of age
DIETARY_SUPPLEMENTPlacebo
Given daily from 14 days of age until 9 months of age
Sponsors
University of Copenhagen
Chr Hansen
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participant, Care Provider, Investigator, Outcomes Assessor
Intervention model description
A randomized, controlled trial in term newborns with an 8½ months intervention period from 14 days of age until 9 months of age followed by a 3 months short-term follow-up period until 1 year of age and a long-term follow-up until 18 years of age
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for the pregnant person 1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0) 2. Singleton pregnancy 3. Ability to read and speak Danish 4. Plan to breastfeed 5. Provided voluntary written informed consent. Inclusions Criteria for the newborn 1. Born at full-term ≥37+0 2. Birth weight ≥ 2500 g 3. APGAR score of ≥ 7 within the first 5 min of life.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total abundance of Bifidobacteria | At 3 months of age | Abundance of Bifidobacteria in infant fecal samples by quantitative PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant fecal pH | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year | Changes in Fecal pH measured in fecal water from fecal samples |
| Infant gut microbiome composition | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year | Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing) |
| Proportion of infants with hard or very hard stool consistency | 4 months, 5 months, 6 months | The proportion of infants with episodes 'hard' and/or 'very hard' stool consistency assessed as the difference in numbers of infants who experience 'hard' and /or 'very hard' stool consistency during weaning (from first introduction of solid food) between the two groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant bowel habits | Weekly (0-52 weeks of age) | Changes in bowel habits as measured by stool frequency and stool consistency. The consistency will be assessed by a modified Diapered Infant Stool Scale continuously in an electronic diary weekly from birth to 1 year of age |
| Pediatric Quality of Life Inventory™ 2.0 Family Impact Module (PedsQL™) | 3 months, 6 months, 9 months, and 1 year | Familys health-related quality of life will be measured by Pediatric Quality of Life Inventory™ 2.0 Family Impact Module (PedsQL™) The 36-item PedsQL consists of 6 scales measuring parent self-reported functioning: 1) Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and 2 scales measuring parent-reported family functioning; 7) Daily Activities (3 items) and 8) Family Relationships (5 items). A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) and higher scores indicate better functioning (less negative impact). |
| Infant gut metabolome composition | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year | Changes in the overall infant fecal metabolome assessed by untargeted metabolomics |
| Alarm Distress Baby scale | 3-4 weeks of age, 2-3 months and 8-10 months of age | Infant socioemotional development (stress and failure to thrive) will be measured by the Alarm Distress Baby scale. The scale focuses on eight distinctive areas of infant behaviour: facial expression, eye contact, general level of activity, self-stimulation gestures, vocalisations, briskness of response to stimulation, ability to initiate and maintain a relationship and ability to generate and sustain attention. It is used for infants aged 0-24 months and each item is rated from 0 to 4 with the overall score reflecting an interpretation of the baby's behaviour in a given situation. A score of 5 or above is indicative of relational withdrawal. A low score means a better outcome. |
| Infant blood metabolome | 3 months, 6 months, 9 months, and 1 year | Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots |
| Quantity of metabolites in infant fecal samples | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year | Quantification of metabolites in infant fecal samples measured by targeted metabolomics |
| Infant Whole Gut Transit Time | 9 months and 1 year | Whole gut transit time measured by sweet corn test |
| Abundance of clinically relevant pathogens in feces | Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year | Abundance of clinically relevant pathogens in feces (e.g., but not limited to Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Pseudomonas aeruginosa, Enterobacter, Klebsiella, Proteus, group B Streptococcus, Clostridioides difficile, Bacillus subtilis and Acinetobacter measured by DNA/RNA sequencing of fecal samples |
Countries
Denmark
Contacts
Primary ContactSofie Ingdam Halkjær, MSc, PhD
Outcome results
None listed