Healthy Infants
Conditions
Keywords
Infant, Gastrointestinal Microbiome, Diet, Food, and Nutrition
Brief summary
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain. The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
Interventions
OTHERProbiotic
Given daily from enrollement to 28 days of life
DIETARY_SUPPLEMENTPlacebo
Given daily from enrollement to 28 days of life
Sponsors
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 of healthy term in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria for the pregnant person: 1. Healthy pregnant person in gestational week 36+0-38+0 2. Age ≥ 18 years 3. Normal singleton pregnancy 4. Ability to read and speak Danish 5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks 6. Plan to exclusively breastfeed 7. Provided voluntary written informed consent. * Inclusions Criteria for the newborn: 1. Born at full-term ≥37+0 2. Birth weight above 2500 g 3. APGAR score of at least 7 within the first 5 min of life.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of the probiotic strain in newborn/infant fecal samples | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks | Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant fecal pH | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks | Changes in Fecal pH measured in fecal water from fecal samples. |
| Total abundance of bifidobacteria | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks | Abundance of fecal bifidobacteria measured by quantitative PCR |
| Infant fecal short chain fatty acids (SCFA) | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks | Changes in SCFA production as measured by targeted metabolomics |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant bowel habits stool consistency | Daily from 0-6 weeks of age | Changes in bowel habits as measured by stool consistency. The consistency will be assessed by a modified diapered infant stool scale. |
| Infant growth, weight | Birth, 4 weeks, 6 weeks of age. | Infant weight in kilograms will be aggregated to determine infant growth status. |
| Infant crying and fussing | Daily (0-6 weeks of age) | Measured as frequency and duration (hours/minutes per day) of crying and fussing |
| Infant gut metabolome | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks | Characterization and changes in the Infant fecal metabolome as assessed by targeted and untargeted metabolomics in infant fecal samples |
| Pregnant person blood metabolome | 36+0-38+0 GA weeks | Characterization of the pregnant person blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots |
| Infant growth, length | Birth, 4 weeks, 6 weeks of age. | Infant length in centimeters will be aggregated to determine infant growth status. |
| Infant growth, head circumference | Birth, 4 weeks, 6 weeks of age. | Infant head circumference in centimeters will be aggregated to determine infant growth status. |
| Pregnant person fecal microbiota composition | 36+0-38+0 GA weeks | Gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples |
| Infant gut microbiome composition | Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks | Changes in gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples |
| Infant blood metabolome | 4 weeks | Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots |
| Infant bowel habits frequency | Daily (0-6 weeks of age) | Changes in bowel habits as measured by daily stool frequency. |
Countries
Denmark
Contacts
Primary ContactSofie Ingdam Halkjær, MSc, PhD
Outcome results
None listed