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Restoration of the Gut Microbiome After Cesarean Section

"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Placebo-controlled Trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06264219
Acronym
RestoreGut
Enrollment
80
Registered
2024-02-16
Start date
2024-08-02
Completion date
2027-08-30
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

Brief 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.

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.

Interventions

BIOLOGICALMicrobiome restoration - FMT

Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.

BIOLOGICALMicrobiome restoration - FVT

Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.

BIOLOGICALPlacebo

Inactive solution buffer

OTHERVaginal birth, untreated control

No intervention. This group is for secondary outcomes comparisons.

Sponsors

Jakob Stokholm
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Microbial compositional differences compared with placebo-treated infantsAt 1 week of ageIntestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.

Secondary

MeasureTime frameDescription
Microbial compositional differences compared with placebo-treated infantsDuring the first year of lifeIntestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Microbial compositional resemblance to vaginally-born infantsAt 1 week of ageIntestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.
Virome compositional differences compared with placebo-treated infantsAt 1 week of ageIntestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.
Virome compositional differences compared with vaginally-born infantsAt 1 week of ageIntestinal virome composition, assessed by metagenomic sequencing of fecal viral DNA, quantified by beta-diversity indices.

Countries

Denmark

Contacts

CONTACTJakob Stokholm, MD, PhD
stokholm@copsac.com+45 38677360
CONTACTKaare D. Tranæs, Msc
kaare.tranaes@dbac.dk+45 38677360
STUDY_CHAIRKlaus Bønnelykke, MD, PhD

Head of COPSAC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026