Fecal bacteriophage transfer to help preterm infants' gut health
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Clinical Trial
EARLY_PHASE1 · Rigshospitalet, Denmark · NCT05272579
This study is testing if giving preterm infants healthy gut bacteria from full-term babies can help improve their gut health and prevent serious digestive problems.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05272579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born between 26 and 30 weeks gestation who are admitted to the NICU.
Not a fit: Patients with major congenital anomalies or those requiring extensive medical support prior to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of necrotizing enterocolitis in preterm infants.
How similar studies have performed: While the use of bacteriophages is a novel approach in this context, similar studies have shown promise in other areas of microbiome-related treatments.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
Study contacts
- Principal investigator: Lise Aunsholt, md, phd — Rigshospitalet, Denmark
- Study coordinator: Gustav R Jakobsen, md
- Email: gustav.riemer.jakobsen@regionh.dk
- Phone: +4550569536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Necrotizing Enterocolitis, Microbial Substitution