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

NCT05272579 | Recruiting Early Phase 1

• 1 other identifier: Rigshospitalet - PrePhage
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Recruiting and following healthy donor infants to study the microbiota and use feces from them to donate in stage 2 and 3
2. 2.Examining the safety of the treatment as well as how it works in preterm piglets
3. 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.

Conditions

Necrotizing Enterocolitis; Microbial Substitution

Outcome Measures

Primary Outcomes (1)

• No serious adverse events

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

  14 days

Secondary Outcomes (12)

• Feeding tolerance

  1 month

• Microbiota Composition

  1 month

• Time to full enteral feeding

  1 month

• Blood pressure

  1 month

• Temperature

  1 month

Study Arms (2)

FFT treatment

EXPERIMENTAL

Treatment with fecal filtrate transfer in saline solution administered by nasogastric tube

Other: Fecal Filtrate Transfer

Placebo Treatment

PLACEBO COMPARATOR

Treatment with saline solution administered by nasogastric tube

Other: Placebo

Interventions

Fecal Filtrate Transfer OTHER

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

FFT treatment

Placebo OTHER

Saline solution

Placebo Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ability to give informed consent
• ● 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Lise Aunsholt, Neonatologist, Clinical Professor: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• Kappel SS, Jakobsen GR, Oestergaard KL, Brunse A, Nielsen DS, Aunsholt L. Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations. Acta Paediatr. 2025 Oct 6. doi: 10.1111/apa.70333. Online ahead of print.

  PMID: 41051016 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Lise Aunsholt, md, phd

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustav R Jakobsen, md

CONTACT

+4550569536; gustav.riemer.jakobsen@regionh.dk

Lise Aunsholt, md, phd

CONTACT

+4561991137; lise.aunsholt@regionh.dk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Ph.d-student

Model Details: In a block randomized trial with 14 days of follow up between each step, a total of 10 infants will be treated with fecal filtrate transfer and 10 infants will be treated with placebo. The structure will be: 2+2, 2+2, 2+2, 6+6

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 9, 2022
• Study Start: November 7, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE

Locations

DK (1)