Restoring gut bacteria in infants born by cesarean section

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.