Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06264219
Other study ID # H-24002284
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date November 30, 2026

Study information

Verified date February 2024
Source Copenhagen Studies on Asthma in Childhood
Contact Jakob Stokholm, MD, PhD
Phone +45 38677360
Email stokholm@copsac.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We 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.


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. We hypothesize that early intervention with mother-to-infant FMT can restore a CS-perturbed microbiome to a normal microbial trajectory. We also hypothesize 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date November 30, 2026
Est. primary completion date November 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Microbiome restoration - FMT
Pathogen-free microbiota from maternal stool sample is transferred from mother to infant.
Microbiome restoration - FVT
Sterile-filtered and ultracentrifuged FMT, containing only viruses, is transferred from mother to infant.
Placebo
Inactive solution buffer
Other:
Vaginal birth, untreated control
No intervention. This group is for secondary outcomes comparisons.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen
Denmark Copsac, DBAC Gentofte Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Professor Klaus Bønnelykke

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbial development trajectory Compositional differences to placebo-treated infants During the first year of life
Secondary Microbial development trajectory Compositional resemblance to vaginally-born infants During the first year of life
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT04122612 - Shaping Microbiome in the First 1,000 Days of Life
Not yet recruiting NCT05405634 - Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Not yet recruiting NCT04895774 - Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Completed NCT05175833 - Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19 Phase 2
Recruiting NCT04836910 - Microbiome and Polycystic Ovaries
Recruiting NCT05603650 - Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract N/A
Completed NCT04991818 - MSC - OneBiome UX Pilot Study N/A
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Recruiting NCT04140747 - Transfer of Strictly Anaerobe Microbes From Mother to Child
Recruiting NCT04111471 - The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Completed NCT03422562 - Probiotics and Intestinal Microbiome in Preterm Infants Phase 3
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1