Characterization of the Gastrointestinal Microbiota in Newborn Infants (BABIES I)

Hvidovre University Hospital

Status: Enrolling

Conditions: Healthy Infants

Treatments: Other: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06789484

H-24073138 (Other Identifier)

HND-IN-056

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Probiotic Dietary supplement

Treatment:

Other: Probiotic

Placebo

Placebo Comparator group

Description:

Identical looking placebo consisting of maltodextrin

Treatment:

Dietary Supplement: Placebo