NCT05272579 PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
| NCT ID | NCT05272579 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Necrotizing Enterocolitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-07 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-11-07 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Lise Aunsholt, md, phd
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05272579 clinical trial?
This trial is open to participants of all sexes, studying Necrotizing Enterocolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05272579 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05272579 currently recruiting?
Yes, NCT05272579 is actively recruiting participants. Contact the research team at gustav.riemer.jakobsen@regionh.dk for enrollment information.
Where is the NCT05272579 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05272579 clinical trial?
NCT05272579 is sponsored by Rigshospitalet, Denmark. The principal investigator is Lise Aunsholt, md, phd at Rigshospitalet, Denmark. The trial plans to enroll 20 participants.