Characterization of the Gastrointestinal Microbiota in Newborn Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Infants. Basic parameters: up to 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
Overview
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
- Other Probiotic
Given daily from enrollement to 28 days of life - Dietary supplement Placebo
Given daily from enrollement to 28 days of life
Primary outcome measures
- Recovery of the probiotic strain in newborn/infant fecal samples [Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks]
Secondary outcome measures (3)
- Infant fecal pH [Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks]
- Total abundance of bifidobacteria [Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks]
- Infant fecal short chain fatty acids (SCFA) [Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks]
Eligibility criteria
Inclusion criteria
- Inclusion Criteria for the pregnant person:
- Healthy pregnant person in gestational week 36+0-38+0
- Age ≥ 18 years
- Normal singleton pregnancy
- Ability to read and speak Danish
- Normal ultrasound scan of the fetus at gestational age 19-20 weeks
- Plan to exclusively breastfeed
- Provided voluntary written informed consent.
- Inclusions Criteria for the newborn:
- Born at full-term ≥37+0
- Birth weight above 2500 g
- APGAR score of at least 7 within the first 5 min of life.
Exclusion criteria
- Exclusion Criteria for the pregnant person:
- Pregnancy at over 38+0 weeks' gestation at recruitment
- Multiple pregnancy
- Pregnancy with any fetal abnormality
- Alcohol or drug abuse
- Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
- Any contraindications for breastfeeding.
Exclusion Criteria for the newborn :
- Congenital disorders that could affect their safety or the study outcome
- Admission to Neonatal Intensive Care Unit for more than 24 hours
- Participation in another clinical intervention study which can interfere with this probiotic intervention
- No other probiotics than the study product.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling — Hvidovre
Identifiers
NCT: NCT06789484 · HND-IN-056 · H-24073138