Status:
COMPLETED
Prephage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Donor Study
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Lise Aunsholt, Neonatologist, Clinical Professor
Conditions:
Feeding Patterns
Microbial Colonization
Eligibility:
All Genders
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...
Detailed Description
Detailed Description: PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot trial aims to investigate if fecal filtrate transfers (FFT)...
Eligibility Criteria
Inclusion
- Inclusion criteria for infants
- 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.
- Exclusion criteria for infants
- Antibiotic exposure before collection of faecal material for donation,
- Disease between time of birth and collection of feces for donation,
- Major congenital anomalies or birth defects, perinatal asphyxia, need for mechanical ventilation or cardiovascular support before time of inclusion.
- 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
- Inclusion criteria for mothers
- Women aged 18-45 and currently healthy
- No continuous medical consumption with effects on microbiome
- Non-smoking
- Ability to give informed consent
- Exclusion criteria for mothers
- 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
- Gestational diabetes
- Family history of inflammatory bowel disease
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05272566
Start Date
April 1 2022
End Date
March 20 2024
Last Update
June 4 2024
Active Locations (1)
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1
Gustav R Jakobsen
Copenhagen, Denmark, 2100