Infant, NewbornMaMiNCT07212361
Infant Microbiota Restoration With Maternal Microbes
A study testing Probiotic in people with Infant, Newborn and Gut -Microbiota, run by University of Helsinki at 2 sites in Finland.
Trial summary
The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is: Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut… Read more about this study
- Who is it for?
- Ages Up to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Gut -Microbiota, Gut Dysbiosis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- 17 Jul 2025to 31 Dec 2035
- 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 Up to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy mother and healthy pregnancy
- Singleton pregnancy,
- Mothers who speak Finnish or Swedish
- Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
- Infants who are expected to be healthy and who will not require BCG vaccination.
Who cannot join
- Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
- Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
- Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
- Premature infants born before the pregnancy week 37
- Infants, who are born by urgent cesarean section or emergency cesarean section
- Infants, who receive antibiotics during the first week of life
- Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.
- Infants, who receive BCG-vaccine
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marjo Metsäranta, MD, PhD contact
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Marjo Metsäranta, MD, PhD, +358504272487, marjo.metsaranta@hus.fi
- Recruiting
University of Helsinki
Helsinki
Katri E Korpela, PhD, +358504486369, katri.korpela@helsinki.fi
About this study
The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:
Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.
Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.
Read the detailed description
The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.
- Conditions
- Infant, Newborn, Gut -Microbiota, Gut Dysbiosis, Cesarean Delivery Affecting Newborn, Cesarean Section, Vaginal Delivery
- Being tested
- Probiotic, Placebo
- Keywords
- Infant, newborn, cesarean section, neonate, restore, gut microbiota
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
PlaceboOther
Infant formula without bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | The infants will receive a mixture of probiotic strains currently on the market and with known safety profiles and beneficial effects on infant gut microbiota. Receives: Dietary Supplement: Probiotic |
| Vaginal delivery | No intervention | Not described |
| Maternal bacteria set 1 | Experimental | The infants will receive a micture of bacteria isolated from a fecal sample of the infants' own mother. Receives: Dietary Supplement: Probiotic |
| Maternal bacteria set 2 | Experimental | The infants will receive a mixture of bacterial species with increased diversity isolated from the mother's sample. Receives: Dietary Supplement: Probiotic |
| Maternal bacteria set 3 | Other | The infants will receive a mixture of bacterial strains isolated from other infants' and/or mothers' samples to test whether bacteria from an unrelated donor have different effects compared to maternal bacteria. In this group all infants will receive the same standardised mixture of bacterial strains. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | C-section born infants given a placebo treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition, relative and absolute abundances
Similarity of the overall gut, mouth, and skin microbiota composition
Measured: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.
Fecal metabolite profiles
Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group.
Measured: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start17 Jul 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Katri Korpela, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212361
- Sponsor's protocol ID
- HUS/617/2025/71
- Acronym
- MaMi
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Oct 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Microbiota Restoration With Maternal Microbes
- ClinicalTrials.gov ID
- NCT07212361
- Acronym / sponsor ID
- MaMi / HUS/617/2025/71
- Conditions
- Infant, Newborn, Gut -Microbiota, Gut Dysbiosis, Cesarean Delivery Affecting Newborn, Cesarean Section, Vaginal Delivery
- Keywords
- Infant, newborn, cesarean section, neonate, restore, gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 8 Oct 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 goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:
Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.
Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.
Detailed description
The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticThe infants will receive a mixture of probiotic strains currently on the market and with known safety profiles and beneficial effects on infant gut microbiota. |
| Vaginal delivery | No intervention | – |
| Maternal bacteria set 1 | Experimental | Dietary Supplement: ProbioticThe infants will receive a micture of bacteria isolated from a fecal sample of the infants' own mother. |
| Maternal bacteria set 2 | Experimental | Dietary Supplement: ProbioticThe infants will receive a mixture of bacterial species with increased diversity isolated from the mother's sample. |
| Maternal bacteria set 3 | Other | Dietary Supplement: ProbioticThe infants will receive a mixture of bacterial strains isolated from other infants' and/or mothers' samples to test whether bacteria from an unrelated donor have different effects compared to maternal bacteria. In this group all infants will receive the same standardised mixture of bacterial strains. |
| Placebo | Placebo comparator | Other: PlaceboC-section born infants given a placebo treatment. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy mother and healthy pregnancy
- Singleton pregnancy,
- Mothers who speak Finnish or Swedish
- Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
- Infants who are expected to be healthy and who will not require BCG vaccination.
Key exclusion criteria (8 listed)
- Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
- Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
- Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
- Premature infants born before the pregnancy week 37
- Infants, who are born by urgent cesarean section or emergency cesarean section
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 |
|---|---|---|
| ProbioticSpecific infant-adapted commercially available strains or strains isolated from the infant's mother. | Dietary supplement | Maternal bacteria set 1, Maternal bacteria set 2, Maternal bacteria set 3, Probiotic |
| PlaceboInfant formula without bacteria. | Other | Placebo |
Primary outcome
Microbiota composition, relative and absolute abundances
Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.
Similarity of the overall gut, mouth, and skin microbiota composition
Fecal metabolite profiles
Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks
Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group.
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 8 Oct 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.
Marjo Metsäranta, MD, PhD contact
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 Infant, Newborn and Gut -Microbiota, run by University of Helsinki at 2 sites 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 5 inclusion and 8 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 8 Oct 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 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 Katri E Korpela, PhD (+358504486369, katri.korpela@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota composition, relative and absolute abundances (time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.). The study lists 2 primary outcomes in all. 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 8 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.