Probiotic for Infants

NCT07054216 | Recruiting

• 2 other identifiers: HND-IN-057H-25028285
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 2

Brief Summary

The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.

Conditions

Healthy Infants

Keywords

Infant; Gastrointestinal Microbiome; Diet, Food, and Nutrition

Outcome Measures

Primary Outcomes (1)

• Total abundance of Bifidobacteria

  Abundance of Bifidobacteria in infant fecal samples by quantitative PCR

  At 3 months of age

Secondary Outcomes (3)

• Infant fecal pH

  Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year

• Infant gut microbiome composition

  Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year

• Proportion of infants with hard or very hard stool consistency

  4 months, 5 months, 6 months

Other Outcomes (8)

• Infant gut metabolome composition

  Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year

• Quantity of metabolites in infant fecal samples

  Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year

• Infant Whole Gut Transit Time

  9 months and 1 year

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 14 days of age until 9 months of age

Probiotic

Placebo DIETARY_SUPPLEMENT

Given daily from 14 days of age until 9 months of age

Placebo

Eligibility Criteria

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

You may qualify if:

• Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
• Singleton pregnancy
• Ability to read and speak Danish
• Plan to breastfeed
• Provided voluntary written informed consent.
• Born at full-term ≥37+0
• Birth weight ≥ 2500 g
• APGAR score of ≥ 7 within the first 5 min of life.

You may not qualify if:

• Pregnancy at 38 weeks + 0 or later at the time of recruitment
• Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks
• Alcohol or drug abuse
• Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
• Pregnant person with 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
• Probiotics other than the study product.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Chr Hansen: collaborator

Study Sites (2)

Hvidovre Hospital

Hvidovre, Region Sjælland, 2650, Denmark

RECRUITING

Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling

Hvidovre, 2650, Denmark

NOT YET 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

+45 38 62 38 62; 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 in term newborns with an 8½ months intervention period from 14 days of age until 9 months of age followed by a 3 months short-term follow-up period until 1 year of age and a long-term follow-up until 18 years of age

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 8, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)