Fecal bacteriophage transfer to help preterm infants' gut health

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 pilot trial investigates the safety and tolerability of fecal filtrate transfers (FFT) from healthy term infants to preterm infants born between 26 and 30 weeks gestation. The study will recruit 20 donor infants and their mothers, collecting fecal samples over three years to assess microbiota development and safety. Preterm infants will be block randomized to receive either FFT or a saline placebo shortly after birth. The ultimate goal is to develop a treatment to prevent necrotizing enterocolitis, a severe gut disease affecting preterm infants.

Why it matters

Who can join: the full rules

Inclusion criteria for participant preterm infants

* Preterm infants born between GA 26+0 and 30+6
* Delivery at RH or transferred to RH NICU within 24 hours of delivery
* Children administered prophylactic antibiotics due to maternal risk factors, specifically: premature rupture of membranes, groub b streptococcus positive, feber during labour
* Signed parental consent

Exclusion criteria for participant preterm infants

* Major congenital anomalies or birth defects
* Antibiotics for more than 72 hours after birthExtremely SGA infant (weight SD score \< -3 SD)
* Need for mechanical ventilation or cardiovascular support before first FFT treatment

Inclusion criteria for mothers of participants

* Women aged 18-45
* Ability to give informed consent

Exclusion criteria for participant mothers

● Mothers who have severe infection, defined by need for other treatment to support infection-related comorbidities, besides from antibiotics (e.g. inotropic treatment, iv fluid resuscitation)

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Lise Aunsholt, md, phd — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Gustav R Jakobsen, md
• Email: gustav.riemer.jakobsen@regionh.dk
• Phone: +4550569536

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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.