Characterization of the Gastrointestinal Microbiota in Newborn 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.

The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotic for Infants

NCT07054216

Healthy Infants

RECRUITING NA

Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics

NCT04994834

Gut Microbiota

COMPLETED NA

Characterisation of the Gut Microbiota in Term Infants After Maternal Supplementation of Probiotics

NCT04987593

Infant Development Gut Microbiome

COMPLETED NA

Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

NCT00290576

Duration of Parenteral Nutrition

COMPLETED NA

Probiotics After Discharge

NCT02695784

Microbiota Bacteriophages Infantile Colic +1 more

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, controlled trial of healthy term in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participant, Care Provider, Investigator, Outcomes Assessor

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Probiotic

Probiotic Dietary supplement

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type OTHER

Given daily from enrollement to 28 days of life

Placebo

Identical looking placebo consisting of maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Given daily from enrollement to 28 days of life

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic

Given daily from enrollement to 28 days of life

Intervention Type OTHER

Placebo

Given daily from enrollement to 28 days of life

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy pregnant person in gestational week 36+0-38+0
2. Age ≥ 18 years
3. Normal singleton pregnancy
4. Ability to read and speak Danish
5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks
6. Plan to exclusively breastfeed
7. Provided voluntary written informed consent.
* Inclusions Criteria for the newborn:

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

Exclusion Criteria

1. Pregnancy at over 38+0 weeks' gestation at recruitment
2. Multiple pregnancy
3. Pregnancy with any fetal abnormality
4. Alcohol or drug abuse
5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
6. 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. No other probiotics than the study product.

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes