Characterization of the Gastrointestinal Microbiota in Newborn Infants

NCT06789484 | Recruiting

• 2 other identifiers: HND-IN-056H-24073138
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Infants

Keywords

Infant; Gastrointestinal Microbiome; Diet, Food, and Nutrition

Outcome Measures

Primary Outcomes (1)

• Recovery of the probiotic strain in newborn/infant fecal samples

  Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR.

  Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

Secondary Outcomes (3)

• Infant fecal pH

  Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

• Total abundance of bifidobacteria

  Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

• Infant fecal short chain fatty acids (SCFA)

  Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

Other Outcomes (11)

• Infant gut metabolome

  Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

• Infant gut microbiome composition

  Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

• Infant blood metabolome

  4 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic Dietary supplement

Other: Probiotic

Placebo

PLACEBO COMPARATOR

Identical looking placebo consisting of maltodextrin

Dietary Supplement: Placebo

Interventions

Probiotic OTHER

Given daily from enrollement to 28 days of life

Probiotic

Placebo DIETARY_SUPPLEMENT

Given daily from enrollement to 28 days of life

Placebo

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Born at full-term ≥37+0
• Birth weight above 2500 g
• APGAR score of at least 7 within the first 5 min of life.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Chr Hansen: collaborator

Study Sites (1)

Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andreas Munk Petersen, MD, PhD, DMSc

  Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Ingdam Halkjær, MSc, PhD

CONTACT

+4541318174; sofie.ingdam.halkjaer@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Care Provider, Investigator, Outcomes Assessor
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Andreas Munk Petersen, MD, PhD, DMSc

Model Details: 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

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 23, 2025
• Study Start: March 4, 2025
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)