A Phase 1 interventional study of Microbiome restoration - FMT and Microbiome restoration - FVT in Microbial Colonization, sponsored by Jakob Stokholm. Recruiting at 2 sites in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Jakob Stokholm · Phase 1, Interventional, and Prevention
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.
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.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's planned enrollment of 80 is below the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →This is the only study on the registry with Jakob Stokholm as lead sponsor.
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Exclusion Criteria:
Maternal:
Infant:
Mother-to-infant fecal microbiota transplantation
Biological: Microbiome restoration - FMT
Mother-to-infant fecal virome transplantation
Biological: Microbiome restoration - FVT
Inactive solution buffer placebo
Biological: Placebo
Non-randomized control group used for secondary outcomes comparisons.
Other: Vaginal birth, untreated control
Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Also known as: Fecal Microbiota Transplantation
Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
Also known as: Fecal Virome Transplantation
Inactive solution buffer
No intervention. This group is for secondary outcomes comparisons.
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.
Time frame: At 1 week of age
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the first year of life
Stool metabolite differences compared with placebo-treated infants
Fecal metabolomic profiles, assessed with GC-MS and LC-MS or Nuclear Magnetic Resonance (NMR)
Time frame: At 1 week of age
Stool metabolite differences compared with placebo-treated infants
Fecal metabolomic profiles, assessed with GC-MS and LC-MS or Nuclear Magnetic Resonance (NMR)
Time frame: During the first year of life
Infection incidence rate
Differences in infection counts between treatment groups.
Time frame: During the first year of life
Plan to share: 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).
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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