Healthy InfantsBABIES IINCT07054216
Probiotic for Infants
A study testing Probiotic in people with Healthy Infants, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 2 sitesDenmark
- Study dates
- 25 Aug 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Hvidovre Hospital
Hvidovre, Region Sjælland, 2650
Andreas Munk Petersen, MD, PhD, DMSc, +45 38 62 61 99, andreas.munk.petersen@regionh.dk
- Not yet recruiting
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, 2650
Andreas Munk Petersen, MD, PhD, DMSc, +45 38 62 61 99, andreas.munk.petersen@regionh.dk
About this study
Official title: Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study
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.
- Conditions
- Healthy Infants
- Being tested
- Probiotic, Placebo
- Keywords
- Infant, Gastrointestinal Microbiome, Diet, Food, and Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Given daily from 14 days of age until 9 months of age
PlaceboDietary supplement
Given daily from 14 days of age until 9 months of age
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic Dietary supplement Receives: Other: Probiotic |
| Placebo | Placebo comparator | Identical looking placebo consisting of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total abundance of Bifidobacteria
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
Measured: At 3 months of age
Secondary outcomes (3)
Infant fecal pH
Changes in Fecal pH measured in fecal water from fecal samples
Measured: 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
Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)
Measured: 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
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
Measured: 4 months, 5 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Chr Hansen
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Andreas Munk Petersen, MD, PhD, DMSc, Principal investigator, Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054216
- Sponsor's protocol ID
- HND-IN-057
- Other IDs
- H-25028285
- Acronym
- BABIES II
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07054216
- Acronym / sponsor ID
- BABIES II / HND-IN-057
- Conditions
- Healthy Infants
- Keywords
- Infant, Gastrointestinal Microbiome, Diet, Food, and Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Chr Hansen
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Other: ProbioticProbiotic Dietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical looking placebo consisting of maltodextrin |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticGiven daily from 14 days of age until 9 months of age | Other | Probiotic |
| PlaceboGiven daily from 14 days of age until 9 months of age | Dietary supplement | Placebo |
Primary outcome
Total abundance of Bifidobacteria
Time frame: At 3 months of age
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Munk Petersen, MD, PhD, DMSc principal investigator
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy Infants, run by Hvidovre University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Ingdam Halkjær, MSc, PhD (+45 38 62 38 62, sofie.ingdam.halkjaer@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total abundance of Bifidobacteria (time frame: At 3 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.