Restoration of the Gut Microbiome After Cesarean Section

NCT06264219 | Recruiting Phase 1

• 1 other identifier: H-24002284
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• Microbial compositional differences to placebo-treated infants

  Intestinal microbiome composition, assessed by metagenomic sequencing of fecal matter bacterial DNA, quantified by beta-diversity indices.

  During the first year of life

Secondary Outcomes (1)

• Microbial compositional resemblance to vaginally-born infants

  During the first year of life

Study Arms (4)

FMT (Fecal microbiota transplantation)

ACTIVE COMPARATOR

Mother-to-infant fecal microbiota transplantation

Biological: Microbiome restoration - FMT

FVT (Fecal virome transplantation)

ACTIVE COMPARATOR

Mother-to-infant fecal virome transplantation

Biological: Microbiome restoration - FVT

Placebo

PLACEBO COMPARATOR

Inactive solution buffer placebo

Biological: Placebo

Vaginal control group

OTHER

Non-randomized control group used for secondary outcomes comparisons.

Other: Vaginal birth, untreated control

Interventions

Microbiome restoration - FMT BIOLOGICAL

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

Also known as: Fecal Microbiota Transplantation

FMT (Fecal microbiota transplantation)

Microbiome restoration - FVT BIOLOGICAL

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

Also known as: Fecal Virome Transplantation

FVT (Fecal virome transplantation)

Placebo BIOLOGICAL

Inactive solution buffer

Placebo

Vaginal birth, untreated control OTHER

No intervention. This group is for secondary outcomes comparisons.

Vaginal control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Klaus Bønnelykke: lead

Study Sites (2)

Copsac, DBAC

Gentofte Municipality, Copenhagen, 2820, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Klaus Bønnelykke, MD, PhD

  Head of COPSAC

  STUDY CHAIR

Central Study Contacts

Jakob Stokholm, MD, PhD

CONTACT

+45 38677360; stokholm@copsac.com

Kaare D. Tranæs, Msc

CONTACT

+45 38677360; kaare.tranaes@dbac.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor PhD, Head of COPSAC

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 16, 2024
• Study Start: August 2, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Sequences will be deposited in the Sequence Read Archive repository after publication. External research collaborations are welcome after the initial publication.
• Access Criteria: Sequences will be openly accessible, individual participant data only under research collaborations.

Locations

DK (2)