Probiotic for Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Infants. Basic parameters: 0 Days — 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study
Overview
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.
Interventions
- Other Probiotic
Given daily from 14 days of age until 9 months of age - Dietary supplement Placebo
Given daily from 14 days of age until 9 months of age
Primary outcome measures
- Total abundance of Bifidobacteria [Time frame: At 3 months of age]
Secondary outcome measures (3)
- 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]
- 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]
- Proportion of infants with hard or very hard stool consistency [Time frame: 4 months, 5 months, 6 months]
Eligibility criteria
"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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Denmark · 2 centers
- Hvidovre Hospital — Hvidovre
- Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling — Hvidovre
Identifiers
NCT: NCT07054216 · HND-IN-057 · H-25028285