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New treatment option for Necrotizing Enterocolitis
Official title PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
ClinicalTrials.gov ID: NCT05272579
What this study is testing
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
- Signed parental consent
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.