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

ConditionsNecrotizing EnterocolitisMicrobial Substitution
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRigshospitalet, Denmark

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Women aged 18-45

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal Filtrate Transfer

    Other intervention

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

  • Placebo

    Other intervention

    Saline solution

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: FFT treatmentExperimental treatment 1 intervention
Group B: Placebo TreatmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

No serious adverse events

No increased incidence of sepsis, NEC and death in the treatment group

Time frame
14 days

Secondary outcomes

1

Feeding tolerance

Using a standardized clinical scoring system, nurses at our NICU will evaluate any negative reactions to enteral feeding. It includes evaluation of aspirate, feces, amount of enteral nutrition administered, objective evaluation of the abdomen, and signs of obstipation

Time frame
1 month
2

Microbiota Composition

Total genomic DNA will be subjected to deep metagenome sequencing and related to the study outcomes. When extracting faecal DNA as well as viral DNA/RNA, physical fractionation or selective lysis will be employed to ensure host DNA is kept to a minimum. Remaining host DNA material will be removed during bioinformatics filtering and mapping of the shotgun metagenomics data.

Time frame
1 month
3

Time to full enteral feeding

Time frame
1 month
4

Blood pressure

Blood pressure in mmHg

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Lise Aunsholt, Neonatologist, Clinical Professor

Collaborator

Source ClinicalTrials.gov
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