Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, 2650, Denmark
Location status: Recruiting
Recruiting
NCT Number: NCT06789484
Characterization of the Gastrointestinal Microbiota in Newborn Infants
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 1 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Probiotic
OtherGiven daily from enrollement to 28 days of life
Placebo
Dietary SupplementGiven daily from enrollement to 28 days of life
Primary outcomes
-
Recovery of the probiotic strain in newborn/infant fecal samples
Time frame: 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 outcomes
-
Infant fecal pH
Time frame: 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
Time frame: 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)
Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Changes in SCFA production as measured by targeted metabolomics
Other outcomes
-
Infant gut metabolome
Time frame: 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
-
Infant gut microbiome composition
Time frame: 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
Time frame: 4 weeks
Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots
-
Infant bowel habits frequency
Time frame: Daily (0-6 weeks of age)
Changes in bowel habits as measured by daily stool frequency.
-
Infant bowel habits stool consistency
Time frame: 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
Time frame: Birth, 4 weeks, 6 weeks of age.
Infant weight in kilograms will be aggregated to determine infant growth status.
-
Infant crying and fussing
Time frame: Daily (0-6 weeks of age)
Measured as frequency and duration (hours/minutes per day) of crying and fussing
-
Pregnant person fecal microbiota composition
Time frame: 36+0-38+0 GA weeks
Gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples
-
Pregnant person blood metabolome
Time frame: 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
Time frame: Birth, 4 weeks, 6 weeks of age.
Infant length in centimeters will be aggregated to determine infant growth status.
-
Infant growth, head circumference
Time frame: Birth, 4 weeks, 6 weeks of age.
Infant head circumference in centimeters will be aggregated to determine infant growth status.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hvidovre University Hospital
Other
Collaborators
- Chr Hansen
Registry information
Official study title
Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
Acronym: BABIES I
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jan 23, 2025
- Registry last updated
- Apr 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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