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

Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy Infants
• Intervention / Treatment: Other: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofie Ingdam Halkjær, MSc, PhD; Phone Number: +4541318174; Email: sofie.ingdam.halkjaer@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
    • Contact: Andreas Munk Petersen, MD, PhD, DMSc; Phone Number: +45 38 62 61 99; Email: andreas.munk.petersen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; Probiotic Dietary supplement	Other: Probiotic; Given daily from enrollement to 28 days of life
Placebo Comparator: Placebo; Identical looking placebo consisting of maltodextrin	Dietary supplement: Placebo; Given daily from enrollement to 28 days of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant fecal pH	Changes in Fecal pH measured in fecal water from fecal samples.	Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Total abundance of bifidobacteria	Abundance of fecal bifidobacteria measured by quantitative PCR	Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Infant fecal short chain fatty acids (SCFA)	Changes in SCFA production as measured by targeted metabolomics	Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant gut metabolome	Characterization and changes in the Infant fecal metabolome as assessed by targeted and untargeted metabolomics in infant fecal samples	Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Infant gut microbiome composition	Changes in gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples	Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Infant blood metabolome	Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots	4 weeks
Infant bowel habits frequency	Changes in bowel habits as measured by daily stool frequency.	Daily (0-6 weeks of age)
Infant bowel habits stool consistency	Changes in bowel habits as measured by stool consistency. The consistency will be assessed by a modified diapered infant stool scale.	Daily from 0-6 weeks of age
Infant growth, weight	Infant weight in kilograms will be aggregated to determine infant growth status.	Birth, 4 weeks, 6 weeks of age.
Infant crying and fussing	Measured as frequency and duration (hours/minutes per day) of crying and fussing	Daily (0-6 weeks of age)
Pregnant person fecal microbiota composition	Gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples	36+0-38+0 GA weeks
Pregnant person blood metabolome	Characterization of the pregnant person blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots	36+0-38+0 GA weeks
Infant growth, length	Infant length in centimeters will be aggregated to determine infant growth status.	Birth, 4 weeks, 6 weeks of age.
Infant growth, head circumference	Infant head circumference in centimeters will be aggregated to determine infant growth status.	Birth, 4 weeks, 6 weeks of age.

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Chr Hansen
• Investigators: Principal Investigator: Andreas Munk Petersen, MD, PhD, DMSc, Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Gastrointestinal Microbiome; Infant; Diet, Food, and Nutrition
• Other Study ID Numbers: HND-IN-056; H-24073138 (Other Identifier: Ethics Committee Case number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No