Healthy Newborn InfantsReCoverHealthNCT06974994
Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation
A study testing Synbiotic Supplement in people with Healthy Newborn Infants, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. Read more about this study
- Who is it for?
- Ages 2 hours and older
- Conditions the study is for
- Healthy Newborn Infants
- What is being tested?
- Synbiotic Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteFinland
- Study dates
- 8 May 2024to Dec 2029
- 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 2 hours and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
Who cannot join
- Chorioamnionitis
- Pre-eclampsia and hepatogestosis
- Suspected malformation or serious condition of the foetus and neonates
- Serious infection or other conditions not permitting breast milk feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku
Turku, Valitse Maakunta., 20780
Paula Tähtinen, MD, PhD, +358-2-3130746, paula.tahtinen@utu.fi
paula.tahtinen@utu.fi
About this study
Official title: Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.
- Conditions
- Healthy Newborn Infants
- Being tested
- Synbiotic Supplement, Placebo
- Keywords
- antibiotics, human milk oligosaccharides, probiotics, newborn, microbiome, microbiota, obesity, infectious diseases
- Medical subject headings
- Obesity, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic SupplementDietary supplement
Bifidobacterium bifidum and human milk oligosaccharides (HMOs)
PlaceboOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Active comparator | Bifidobacterium bifidum and human milk oligosaccharides (HMOs) Receives: Dietary Supplement: Synbiotic Supplement |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI at 24 months of age
Child's body mass index (BMI) at the age of 24 months
Measured: From enrollment to 24 months of age
Secondary outcomes (9)
Height
Child's height at the age of 6, 12, 18, and 24 months
Measured: From enrollment to 24 months of age
Weight
Child's weight at the age of 6, 12, 18, and 24 months
Measured: From enrollment to 24 months of age
Growth velocity
Child's growth velocity at 2-3 months of age
Measured: From enrollment to 3 months of age
Child's microbiome
The function and composition of the child's gut, nasal, and mouth microbiome at the age of 2, 6, 12, 18, and 24 months
Measured: From enrollment to 24 months of age
Mother's microbiome
The function and composition of the mother's gut, nasal, and mouth microbiome when the child is 2 and 6 months of age
Measured: From enrollment to 6 months after giving birth
Breast milk microbiome
The composition of breast milk's microbiome when the child is 2 and 6 months of age
Measured: From enrollment to 6 months of age
Hormonal levels
Child's hormonal levels (testosterone, sex hormone-binding globulin, luteinizing hormone and follicle-stimulating hormone) at birth and at the age of 2 and 6 months
Measured: From enrollment to 6 months of age
Inflammatory markers
Systemic inflammation markers (cytokines, C-reactive protein, soluble urokinase-type plasminogen activator receptor and haptoglobulin) at birth and at the age of 2 and 6 months
Measured: From enrollment to 6 months of age
Respiratory tract infections
Respiratory tract infections by the age of 24 months
Measured: From enrollment to 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 May 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Newborn InfantsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Randomized, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Principal investigator, Erika Isolauri, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974994
- Sponsor's protocol ID
- T1927_2023
- Acronym
- ReCoverHealth
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be shared for research purposes upon special request to the PI
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
- ClinicalTrials.gov ID
- NCT06974994
- Acronym / sponsor ID
- ReCoverHealth / T1927_2023
- Conditions
- Healthy Newborn Infants
- Keywords
- antibiotics, human milk oligosaccharides, probiotics, newborn, microbiome, microbiota, obesity, infectious diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Lallemand Health Solutions
- Study start
- 8 May 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 May 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 aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.
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
- Randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Active comparator | Dietary Supplement: Synbiotic SupplementBifidobacterium bifidum and human milk oligosaccharides (HMOs) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 2 hours and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.
Key exclusion criteria (4 listed)
- Chorioamnionitis
- Pre-eclampsia and hepatogestosis
- Suspected malformation or serious condition of the foetus and neonates
- Serious infection or other conditions not permitting breast milk feeding
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 |
|---|---|---|
| Synbiotic SupplementBifidobacterium bifidum and human milk oligosaccharides (HMOs) | Dietary supplement | Synbiotic |
| PlaceboMaltodextrin | Other | Placebo |
Primary outcome
BMI at 24 months of age
Time frame: From enrollment to 24 months of age
Child's body mass index (BMI) at the age of 24 months
9 secondary outcomes
Height
Time frame: From enrollment to 24 months of age
Weight
Time frame: From enrollment to 24 months of age
Growth velocity
Time frame: From enrollment to 3 months of age
Child's microbiome
Time frame: From enrollment to 24 months of age
Mother's microbiome
Time frame: From enrollment to 6 months after giving birth
Breast milk microbiome
Time frame: From enrollment to 6 months of age
Hormonal levels
Time frame: From enrollment to 6 months of age
Inflammatory markers
Time frame: From enrollment to 6 months of age
Respiratory tract infections
Time frame: From enrollment to 24 months of age
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 16 May 2025.
- Individual participant dataSharing planned: Yes. IPD may be shared for research purposes upon special request to the PI
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Supplement in people with Healthy Newborn Infants, run by Turku University Hospital at 1 site in Finland.
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 1 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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 Paula Tähtinen, MD, PhD (+358-2-3130746, paula.tahtinen@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI at 24 months of age (time frame: From enrollment to 24 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 16 May 2025.