Restoring gut bacteria in infants born by cesarean section
"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - a Double-blinded Randomized Controlled Feasibility Trial
This study is testing a new treatment to help restore healthy gut bacteria in infants born by cesarean section to see if it can improve their immune system development.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Copenhagen Studies on Asthma in Childhood Academic / other |
| Locations | 2 sites (Gentofte Municipality, Copenhagen and 1 other locations) |
| Trial ID | NCT06264219 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a therapy to restore the gut microbiome in infants born via cesarean section (CS) by conducting a randomized, placebo-controlled feasibility trial. The intervention involves mother-to-infant fecal microbiota transplantation (FMT) and virome transfer (FVT) to help correct microbial imbalances caused by CS delivery. The study will assess whether these interventions can help the infants' microbiomes resemble those of vaginally born infants, which may support healthier immune system development. The trial will include infants born at less than 38 weeks gestation and will monitor various health outcomes related to microbial colonization.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born via cesarean section who are less than 38 weeks gestational age and whose mothers meet specific health criteria.
Not a fit: Patients who may not benefit from this study include those with chronic health conditions or those who have recently used antibiotics.
Why it matters
Potential benefit: If successful, this approach could lead to improved gut health and immune function in infants born via cesarean section.
How similar studies have performed: Other studies have shown promise in using microbiome restoration techniques, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gentofte Municipality, Copenhagen and 1 other locations
- Copsac, DBAC — Gentofte Municipality, Copenhagen, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Jakob Stokholm, MD, PhD
- Email: stokholm@copsac.com
- Phone: +45 38677360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.