Microbial ColonizationPhase 1RestoreGutNCT06264219
Restoration of the Gut Microbiome After Cesarean Section
A Phase 1 study testing Microbiome restoration - FMT and Microbiome restoration - FVT in people with Microbial Colonization, run by Jakob Stokholm at 2 sites in Denmark.
Trial summary
This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Microbiome restoration - FMT and Microbiome restoration - FVT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- 2 Aug 2024to 30 Aug 2027
- Phase
- Phase 1
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age < week 38+0 days
- Proficient in spoken/written Danish
- Single pregnancy (no twins or triplets)
- Pre-pregnancy BMI between 18.5 and 35 kg/m2
- No chronic intestinal, endocrine, cardiac, or kidney disorders
- No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism)
- No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results.
- Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).
Who cannot join
- Maternal:
- Use of antibiotics within one month of stool donation
- Acute gastroenteritis within one month of stool donation
- Use of antibiotics within one month of birth
- Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk)
- Positive test results for pathogens during donor material screening.
Show all 11Show fewer
- Antibiotic treatment at birth (vaginal births only)
- Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.
- Infant:
- Instances of major birth defects or intrauterine growth retardation (IUGR)
- Infants requiring pediatric support at the time of transplant administration
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
- Not yet recruiting
Rigshospitalet
Copenhagen, 2100
Hanne Hegaard, Professor, +45 27583632, Hanne.Kristine.Hegaard@regionh.dk
- Recruiting
Copsac, DBAC
Gentofte Municipality, Copenhagen, 2820
Jakob Stokholm, MD, PhD, +45 38677360, stokholm@copsac.com
About this study
Official title: "Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Placebo-controlled Trial
This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.
Read the detailed description
When a child is born vaginally, the passage through the birth canal provides the first and very important bacterial colonization. As the child ages, various environmental exposures, such as dietary changes and the presence of older siblings in the home, facilitate a natural maturation of the child's gut microbiome, providing a vast and continuous stimulation of the child's developing immune system. However, factors such as mode of delivery and intrapartum antibiotics can perturb this natural developmental process and cause long-term microbial derangements. The prevalence of cesarean section (CS) birth has increased globally in recent decades, and with it, antibiotic treatment to prevent perinatal infection. Similar patterns have occurred for the prevalence of chronic childhood disease, particularly asthma, with an estimated 300 million asthmatic cases worldwide.
The hypothesis is that early intervention with mother-to-infant FMT can restore a CS-perturbed microbiome to a normal microbial trajectory. Another hypothesis is that seeding the virome fraction (FVT) will cause the neonate's microbiome to resemble the mother's since the transferred phages are enriched and preserved in the intestinal mucus layer, thereby providing the recipient with selective antimicrobial protection while allowing species resembling the mother's own to establish during subsequent bacterial transmission.
- Conditions
- Microbial Colonization
- Being tested
- Microbiome restoration - FMT, Microbiome restoration - FVT, Placebo, Vaginal birth, untreated control
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome restoration - FMTBiological
Also called Fecal Microbiota Transplantation
Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Microbiome restoration - FVTBiological
Also called Fecal Virome Transplantation
Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
PlaceboBiological
Inactive solution buffer
Vaginal birth, untreated controlOther
No intervention. This group is for secondary outcomes comparisons.
| Study group | Role | What they receive |
|---|---|---|
| FMT (Fecal microbiota transplantation) | Active comparator | Mother-to-infant fecal microbiota transplantation Receives: Biological: Microbiome restoration - FMT |
| FVT (Fecal virome transplantation) | Active comparator | Mother-to-infant fecal virome transplantation Receives: Biological: Microbiome restoration - FVT |
| Placebo | Placebo comparator | Inactive solution buffer placebo Receives: Biological: Placebo |
| Vaginal control group | Other | Non-randomized control group used for secondary outcomes comparisons. Receives: Other: Vaginal birth, untreated control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial compositional differences compared with placebo-treated infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Measured: At 1 week of age
Secondary outcomes (7)
Microbial compositional differences compared with placebo-treated infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Measured: During the first year of life
Microbial compositional resemblance to vaginally-born infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Measured: At 1 week of age
Microbial compositional resemblance to vaginally-born infants
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Measured: During the first year of life
Virome compositional differences compared with placebo-treated infants
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Measured: At 1 week of age
Virome compositional differences compared with placebo-treated infants
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Measured: During the first year of life
Virome compositional differences compared with vaginally-born infants
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Measured: At 1 week of age
Virome compositional differences compared with vaginally-born infants
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Measured: During the first year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start2 Aug 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakob Stokholm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakob Stokholm, Copenhagen Studies on Asthma in Childhood
- Investigators
- Klaus Bønnelykke, MD, PhD, Study chair, Head of COPSAC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264219
- Sponsor's protocol ID
- H-24002284
- Acronym
- RestoreGut
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level personally identifiable clinical data from the children participating in the cohort cannot be made freely available, to protect the privacy of the participants and their families, in accordance with the Danish Data Protection Act and European Regulation 2016/679 of the European Parliament and of the Council (GDPR) that prohibit distribution even in pseudo-anonymized form. However, research collaborations are welcome, and data can be made available under a joint research collaboration by contacting the COPSAC Data Protection Officer (DPO), Ulrik Ralfkiaer, PhD (dpo@dbac.dk).
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06264219
- Acronym / sponsor ID
- RestoreGut / H-24002284
- Conditions
- Microbial Colonization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jakob StokholmUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 16 Feb 2024 (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.
This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.
Detailed description
When a child is born vaginally, the passage through the birth canal provides the first and very important bacterial colonization. As the child ages, various environmental exposures, such as dietary changes and the presence of older siblings in the home, facilitate a natural maturation of the child's gut microbiome, providing a vast and continuous stimulation of the child's developing immune system. However, factors such as mode of delivery and intrapartum antibiotics can perturb this natural developmental process and cause long-term microbial derangements. The prevalence of cesarean section (CS) birth has increased globally in recent decades, and with it, antibiotic treatment to prevent perinatal infection. Similar patterns have occurred for the prevalence of chronic childhood disease, particularly asthma, with an estimated 300 million asthmatic cases worldwide.
The hypothesis is that early intervention with mother-to-infant FMT can restore a CS-perturbed microbiome to a normal microbial trajectory. Another hypothesis is that seeding the virome fraction (FVT) will cause the neonate's microbiome to resemble the mother's since the transferred phages are enriched and preserved in the intestinal mucus layer, thereby providing the recipient with selective antimicrobial protection while allowing species resembling the mother's own to establish during subsequent bacterial transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FMT (Fecal microbiota transplantation) | Active comparator | Biological: Microbiome restoration - FMTMother-to-infant fecal microbiota transplantation |
| FVT (Fecal virome transplantation) | Active comparator | Biological: Microbiome restoration - FVTMother-to-infant fecal virome transplantation |
| Placebo | Placebo comparator | Biological: PlaceboInactive solution buffer placebo |
| Vaginal control group | Other | Other: Vaginal birth, untreated controlNon-randomized control group used for secondary outcomes comparisons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Gestational age < week 38+0 days
- Proficient in spoken/written Danish
- Single pregnancy (no twins or triplets)
- Pre-pregnancy BMI between 18.5 and 35 kg/m2
- No chronic intestinal, endocrine, cardiac, or kidney disorders
Key exclusion criteria (11 listed)
- Use of antibiotics within one month of stool donation
- Acute gastroenteritis within one month of stool donation
- Use of antibiotics within one month of birth
- Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk)
- Positive test results for pathogens during donor material screening.
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 |
|---|---|---|
| Microbiome restoration - FMTAlso: Fecal Microbiota TransplantationPathogen-free microbiota from maternal stool sample is transferred from mother to infant. | Biological | FMT (Fecal microbiota transplantation) |
| Microbiome restoration - FVTAlso: Fecal Virome TransplantationSterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant. | Biological | FVT (Fecal virome transplantation) |
| PlaceboInactive solution buffer | Biological | Placebo |
| Vaginal birth, untreated controlNo intervention. This group is for secondary outcomes comparisons. | Other | Vaginal control group |
Primary outcome
Microbial compositional differences compared with placebo-treated infants
Time frame: At 1 week of age
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
7 secondary outcomes
Microbial compositional differences compared with placebo-treated infants
Time frame: During the first year of life
Microbial compositional resemblance to vaginally-born infants
Time frame: At 1 week of age
Microbial compositional resemblance to vaginally-born infants
Time frame: During the first year of life
Virome compositional differences compared with placebo-treated infants
Time frame: At 1 week of age
Virome compositional differences compared with placebo-treated infants
Time frame: During the first year of life
Virome compositional differences compared with vaginally-born infants
Time frame: At 1 week of age
Virome compositional differences compared with vaginally-born infants
Time frame: During the first year of life
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual-level personally identifiable clinical data from the children participating in the cohort cannot be made freely available, to protect the privacy of the participants and their families, in accordance with the Danish Data Protection Act and European Regulation 2016/679 of the European Parliament and of the Council (GDPR) that prohibit distribution even in pseudo-anonymized form. However, research collaborations are welcome, and data can be made available under a joint research collaboration by contacting the COPSAC Data Protection Officer (DPO), Ulrik Ralfkiaer, PhD (dpo@dbac.dk).
Related trials for Microbial Colonization
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
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.
Klaus Bønnelykke, MD, PhD study chair
Head of COPSAC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microbiome restoration - FMT and Microbiome restoration - FVT in people with Microbial Colonization, run by Jakob Stokholm 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 8 inclusion and 11 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 7 Oct 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jakob Stokholm, MD, PhD (+45 38677360, stokholm@copsac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial compositional differences compared with placebo-treated infants (time frame: At 1 week 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 7 Oct 2026.