Clinical study
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
| Status | Recruiting |
|---|---|
| Type | Adjacent product trial |
| Countries | Denmark |
| Conditions studied | Necrotizing Enterocolitis; Microbial Substitution |
| Study years | 2023–2025 (estimated) |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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)
Study description
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 shown potential in the treatment of various diseases. By collecting feces from healthy, term infants and filtering it thoroughly, the investigators can provide a treatment that contains practically only viruses, proteins and nutrients. It is our belief that giving the preterm infants a mix of viruses including bacteriophages will prevent NEC. To do this, the investigators will go through 3 stages: 1. Recruiting and following healthy donor infants to study the microbiota and use feces from them to donate in stage 2 and 3 2. Examining the safety of the treatment as well as how it works in preterm piglets 3. Testing the treatment in preterm infants. 10 preterm infants will receive the treatment and 10 preterm infants will receive placebo. The investigators expect to see no serious side effects to the treatment. The investigators hope, but do not expect to be able to see a beneficial effect of the treatment. If this pilot trial shows promising results, it will be followed be a larger clinical trial.
Study registrations
| ClinicalTrials.gov | NCT05272579 |
|---|
Recorded study locations (1)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Notes from the source review
- Fecal filtrate containing viruses/proteins; adjacent microbiome intervention, not a purified personalized antibacterial phage cocktail. Planned completion date has passed while registry status remains nonterminal; recheck with site.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct05272579 |
|---|