Microbiome restoration - FMT
BiologicalPathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Other names: Fecal Microbiota Transplantation
NCT Number: NCT06264219
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 1
Copsac, DBAC, Gentofte Municipality, Copenhagen, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Maternal:
Infant:
Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Other names: Fecal Microbiota Transplantation
Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
Other names: Fecal Virome Transplantation
Inactive solution buffer
No intervention. This group is for secondary outcomes comparisons.
Time frame: At 1 week of age
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
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Time frame: At 1 week of age
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
Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Time frame: At 1 week of age
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Time frame: During the first year of life
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Time frame: At 1 week of age
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Time frame: During the first year of life
Intestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Time frame: At 1 week of age
Fecal metabolomic profiles, assessed with GC-MS and LC-MS or Nuclear Magnetic Resonance (NMR)
Time frame: During the first year of life
Fecal metabolomic profiles, assessed with GC-MS and LC-MS or Nuclear Magnetic Resonance (NMR)
Contact information is provided by the study sponsor or research team.
Jakob Stokholm, MD, PhD
CONTACT
Kaare D. Tranæs, Msc
CONTACT
Jakob Stokholm
Other
"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Placebo-controlled Trial
Acronym: RestoreGut
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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