Characterization of the Gastrointestinal Microbiota in Newborn Infants

Not Applicable

Recruiting

• Conditions: Healthy Infants

• Registration Number: NCT06789484
• Lead Sponsor: Hvidovre University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Study Start: 2025-03-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling; 🇩🇰 Hvidovre, Denmark