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PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants

RecruitingEARLY Phase 1Ages any - anyAllCopenhagen University Hospital, Rigshospitalet
NCT05272579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term infants to preterm infants born between gestational age (GA) 26 + 0 and 30+6. The long-term goal is to develop a safe and effective treatment to prevent the severe gut disease called necrotizing enterocolitis (NEC). NEC is a common disease in neonatal intensive care units affecting 5-10% of all admitted patients. 15-30% of the affected children die from the disease, and many of the survivors suffer from the effects of extensive gut surgery. While the disease is caused by many different factors, recent research has shown the gut microbiome to be a central factor in the development of NEC. Furthermore, in the recent years special viruses called bacteriophages have

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📋 Eligibility rules (as published)
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)
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What it tests

  • Fecal Filtrate Transfer
  • Placebo
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Where

1 site
Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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