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

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.

Conditions

• Necrotizing Enterocolitis
• Microbial Substitution

Interventions

OTHER

Fecal Filtrate Transfer

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

OTHER

Placebo

Saline solution

Sponsors & Collaborators

• Lise Aunsholt, Neonatologist, Clinical Professor

  collaborator UNKNOWN

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Lise Aunsholt, md, phd · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-07

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Denmark

Study Locations