Prephage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Donor Study

NCT05272566 | Completed

• 1 other identifier: PrePhage, Donor
• Study Type: observational
• Target: 38
• 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: Recruiting and following healthy donor infants to study the microbiota and use feces from them to donate in stage 2 and 3 Examining the safety of the treatment as well as how it works in preterm piglets STAGE 3 will be performed only if stage 2 shows no serious risks for the infants 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

Feeding Patterns; Microbial Colonization

Keywords

Microbiome; Bacteriophage; Feeding Pattern; Stool Pattern

Outcome Measures

Primary Outcomes (1)

• Gut microbiome

  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.

  1 year

Secondary Outcomes (12)

• Clinical development

  1 year

• Weight

  1 year

• Length

  1 year

• Time to establish breastfeeding

  2 weeks

• Length of hospital stay after birth

  1 month

Study Arms (2)

Infants

30 healthy, term infants are recruited for 2 purposes: 1. To study the development of gut bacteria and viruses over time 2. To use as donors in a separate trial

Mothers

30 healthy pregnant women are recruited along with their infants 1. To compare gut bacteria and viruses with those of their children 2. To screen for disease transferrable by breastfeeding

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Families are recruited from out-patients clinics at the secondary level in Copenhagen

You may qualify if:

• The donor must be of term (\>37+0 weeks GA, \< 41+0 weeks GA),
• Be born vaginally with no maternal pre-birth infection,
• Be exclusively breastfed un till fulfilled donation at 4 weeks of age,
• Have no known predisposition for disease.

You may not qualify if:

• Antibiotic exposure before collection of faecal material for donation,
• Disease between time of birth and collection of feces for donation,
• Positive stool sample for C. difficile toxin, parasites or other pathogens
• Positive HIV, HBV, or HCV or CMV
• Parents who do not want to know the HIV, HBV or HCV status of the child
• Women aged 18-45 and currently healthy
• No continuous medical consumption with effects on microbiome
• Non-smoking
• Ability to give informed consent
• Known or high risk of infectious disease such as HIV, HBV, or HCV
• Positive CMV IgM during pregnancy
• Positive stool sample for C. difficile toxin, parasites or other pathogens
• Systemic antibiotic treatment \< 1 months prior to study
• New tattoo \< 1 month prior to study
• Risky sexual behavior

Sponsors & Collaborators

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

Study Sites (1)

Gustav R Jakobsen

Copenhagen, 2100, Denmark

Location

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

Biospecimen

Retention: SAMPLES WITH DNA

Fecal Samples from both mothers and infants, only non-human DNA/RNA analyzed

MeSH Terms

Conditions

Feeding Behavior; Communicable Diseases

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Aunsholt, md, phd

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Ph.d-student

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 9, 2022
• Study Start: April 1, 2022
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Locations

DK (1)