Probiotic for Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2028-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participant, Care Provider, Investigator, Outcomes Assessor

Study Groups

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Probiotic

Probiotic Dietary supplement

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type OTHER

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

Placebo

Identical looking placebo consisting of maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Probiotic

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

Intervention Type OTHER

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

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.

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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes