Clinical trial NCT06789484: Characterization of the Gastrointestinal Microbiota in Newborn Infants
Official title: Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Infants
Keywords: Infant
Gastrointestinal Microbiome
Diet, Food, and Nutrition
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Chr Hansen
First posted: 2025-01-23
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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).


Eligibility criteria: 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:
* Exclusion Criteria for the pregnant person:

  1. Pregnancy at over 38+0 weeks' gestation at recruitment
  2. Multiple pregnancy
  3. Pregnancy with any fetal abnormality
  4. Alcohol or drug abuse
  5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
  6. Any contraindications for breastfeeding.

Exclusion Criteria for the newborn :

1. Congenital disorders that could affect their safety or the study outcome
2. Admission to Neonatal Intensive Care Unit for more than 24 hours
3. Participation in another clinical intervention study which can interfere with this probiotic intervention
4. No other probiotics than the study product.

Primary outcomes:
measure: Recovery of the probiotic strain in newborn/infant fecal samples
timeFrame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Secondary outcomes:
measure: Infant fecal pH
timeFrame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
measure: Total abundance of bifidobacteria
timeFrame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
measure: Infant fecal short chain fatty acids (SCFA)
timeFrame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Other outcomes:
measure: Infant gut metabolome
timeFrame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
measure: Infant gut microbiome composition
timeFrame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
measure: Infant blood metabolome
timeFrame: 4 weeks
measure: Infant bowel habits frequency
timeFrame: Daily (0-6 weeks of age)
measure: Infant bowel habits stool consistency
timeFrame: Daily from 0-6 weeks of age
measure: Infant growth, weight
timeFrame: Birth, 4 weeks, 6 weeks of age.
measure: Infant crying and fussing
timeFrame: Daily (0-6 weeks of age)
measure: Pregnant person fecal microbiota composition
timeFrame: 36+0-38+0 GA weeks
measure: Pregnant person blood metabolome
timeFrame: 36+0-38+0 GA weeks
measure: Infant growth, length
timeFrame: Birth, 4 weeks, 6 weeks of age.
measure: Infant growth, head circumference
timeFrame: Birth, 4 weeks, 6 weeks of age.
Locations:
city: Hvidovre
country: Denmark
facility: Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Study officials:
affiliation: Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
name: Andreas Munk Petersen, MD, PhD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: