Probiotic for Infants (BABIES II)

Hvidovre University Hospital

Status: Enrolling

Conditions: Healthy Infants

Treatments: Dietary Supplement: Placebo; Other: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07054216

H-25028285 (Other Identifier)

HND-IN-057

Details and patient eligibility

About

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.

Enrollment: 378 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

"Inclusion Criteria"

Inclusion Criteria for the pregnant person

1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
2. Singleton pregnancy
3. Ability to read and speak Danish
4. Plan to breastfeed
5. Provided voluntary written informed consent.

Inclusions Criteria for the newborn

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

"Exclusion Criteria" Exclusion Criteria for the pregnant person

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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378 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Probiotic Dietary supplement

Treatment:

Other: Probiotic

Placebo

Placebo Comparator group

Description:

Identical looking placebo consisting of maltodextrin

Treatment:

Dietary Supplement: Placebo