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NCT Number: NCT07054216

Probiotic for Infants

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.

Recruiting

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Key information

Conditions

Healthy Infants

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital, Hvidovre, Region Sjælland, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

"Inclusion Criteria"

Inclusion criteria

for the pregnant person

  • 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.

Inclusions Criteria for the newborn

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

"Exclusion Criteria" Exclusion Criteria for the pregnant person

  • 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.

Exclusion criteria

for the newborn

  • 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.

Treatment and study plan

Probiotic

Other

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Total abundance of Bifidobacteria

    Time frame: At 3 months of age

    Abundance of Bifidobacteria in infant fecal samples by quantitative PCR

Secondary outcomes

  1. Infant fecal pH

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

    Changes in Fecal pH measured in fecal water from fecal samples

  2. Infant gut microbiome composition

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

    Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)

  3. Proportion of infants with hard or very hard stool consistency

    Time frame: 4 months, 5 months, 6 months

    The proportion of infants with episodes 'hard' and/or 'very hard' stool consistency assessed as the difference in numbers of infants who experience 'hard' and /or 'very hard' stool consistency during weaning (from first introduction of solid food) between the two groups

Other outcomes

  1. Infant gut metabolome composition

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

    Changes in the overall infant fecal metabolome assessed by untargeted metabolomics

  2. Quantity of metabolites in infant fecal samples

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

    Quantification of metabolites in infant fecal samples measured by targeted metabolomics

  3. Infant Whole Gut Transit Time

    Time frame: 9 months and 1 year

    Whole gut transit time measured by sweet corn test

  4. Abundance of clinically relevant pathogens in feces

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

    Abundance of clinically relevant pathogens in feces (e.g., but not limited to Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Pseudomonas aeruginosa, Enterobacter, Klebsiella, Proteus, group B Streptococcus, Clostridioides difficile, Bacillus subtilis and Acinetobacter measured by DNA/RNA sequencing of fecal samples

  5. Infant bowel habits

    Time frame: Weekly (0-52 weeks of age)

    Changes in bowel habits as measured by stool frequency and stool consistency. The consistency will be assessed by a modified Diapered Infant Stool Scale continuously in an electronic diary weekly from birth to 1 year of age

  6. Pediatric Quality of Life Inventory™ 2.0 Family Impact Module (PedsQL™)

    Time frame: 3 months, 6 months, 9 months, and 1 year

    Familys health-related quality of life will be measured by Pediatric Quality of Life Inventory™ 2.0 Family Impact Module (PedsQL™) The 36-item PedsQL consists of 6 scales measuring parent self-reported functioning: 1) Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and 2 scales measuring parent-reported family functioning; 7) Daily Activities (3 items) and 8) Family Relationships (5 items). A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) and higher scores indicate better functioning (less negative impact).

  7. Infant blood metabolome

    Time frame: 3 months, 6 months, 9 months, and 1 year

    Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots

  8. Alarm Distress Baby scale

    Time frame: 3-4 weeks of age, 2-3 months and 8-10 months of age

    Infant socioemotional development (stress and failure to thrive) will be measured by the Alarm Distress Baby scale. The scale focuses on eight distinctive areas of infant behaviour: facial expression, eye contact, general level of activity, self-stimulation gestures, vocalisations, briskness of response to stimulation, ability to initiate and maintain a relationship and ability to generate and sustain attention. It is used for infants aged 0-24 months and each item is rated from 0 to 4 with the overall score reflecting an interpretation of the baby's behaviour in a given situation. A score of 5 or above is indicative of relational withdrawal.

    A low score means a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Sofie Ingdam Halkjær, MSc, PhD

CONTACT

[email protected]

+45 38 62 38 62

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Chr Hansen
  • University of Copenhagen

Registry information

Official study title

Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study

Acronym: BABIES II

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 8, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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