RecruitingEarly Phase 1NCT05272579

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

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


Sponsor

Rigshospitalet, Denmark

Enrollment

20 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study investigates whether transferring bacteriophages (viruses that target bacteria) from healthy donor breast milk into the gut of preterm infants can help their digestive system mature more safely. The goal is to find a gentle way to improve gut health in very early preterm babies who receive antibiotics after birth. You may be eligible if (infant): - Your baby was born between 26 and 30 weeks and 6 days of pregnancy - Your baby was delivered at or transferred to the study hospital's NICU within 24 hours of birth - Your baby received preventive antibiotics due to maternal risk factors (water breaking early, group B strep, fever during labor) You may be eligible if (mother): - You are 18 to 45 years old and able to give informed consent You may NOT be eligible (infant) if: - Your baby has major birth defects - Your baby received antibiotics for more than 72 hours after birth - Your baby is extremely small for gestational age (weight SD score below -3) - Your baby needs a mechanical ventilator or heart/circulation support before first treatment You may NOT be eligible (mother) if: - You have a severe infection requiring additional support beyond antibiotics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERFecal Filtrate Transfer

Treatment with donated fecal samples filtered to contain practically no bacteria and mainly viruses, including bacteriophages

OTHERPlacebo

Saline solution


Locations(1)

Rigshospitalet

Copenhagen, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05272579


Related Trials