Feeding PatternsNCT05272566
Prephage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Donor Study
An observational study of Feeding Patterns and Microbial Colonization, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Feeding Patterns, Microbial Colonization
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2022to 20 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Families are recruited from out-patients clinics at the secondary level in Copenhagen
Who may be able to join
- 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.
- Women aged 18-45 and currently healthy
- No continuous medical consumption with effects on microbiome
- Non-smoking
- Ability to give informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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) to preterm infants is safe and tolerable. To investigate this, the investigators will recruit 20 donor infants and their mothers from time of delivery, and both will be subjected to a novel screening program including blood, urine, breastmilk, fecal screening and standard clinical investigation. Donor fecal samples will be collected from time of birth and with varying intervals for consecutive 3 years for 3 purposes: 1) to conduct safety studies in preterm piglets before transfer to preterm recipient infants, 2) to conduct FFT to preterm infants, and 3) to map normal microbiota development in healthy infants. The feces used for donation will be collected between 2-4 weeks after birth. After 1 year, donated feces will be released for FFT to preterm, but only if the donor infant at this time has been healthy and normally developed. Donors are followed up for consecutive 3 years after birth. Maternal fecal samples will be compared to infant samples, to investigate maternal to infant transfer of microbiota, as well as changes in infant microbiota in response to environment.
20 preterm infants with gestational age between 26 +0 - 30+6 weeks + days, are block randomized to either FFT or saline placebo within 24 hours after birth and the following 3 days, in total 4 donations. The recipients are clinically and biochemically closely monitored by attending staff and the group of investigators according to best clinical practice and predefined clinical observation. The recipients are followed up for consecutive 3 years to evaluate potential late side-effects and to monitor change in fecal microbiome after transplant or placebo.
The primary endpoint is to assess safety of FFT to preterm infants with expected no increase in necrotizing enterocolitis (NEC), sepsis and death in the intervention group. The secondary endpoint is to assess if, FFT treatment will reduce incidence of feeding tolerance and improve healthy gut development in recipient preterm infants. The investigators expect to find FFT safe and with fewer cases of NEC and sepsis. The investigators do not expect to prove the effect of the intervention in this study. However, the investigators aim to follow up with a double-blinded multicenter randomized control trial - powered to document our hypothesis - that when colonizing with a healthy microbiome, it is possible decrease incidence of NEC in premature infants.
- Conditions
- Feeding Patterns, Microbial Colonization
- Keywords
- Microbiome, Bacteriophage, Feeding Pattern, Stool Pattern
- Medical subject headings
- Feeding Behavior, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (12)
Clinical development
Clinical evaluation by pediatric doctor, outcome is dichotomous in terms of following normal development or not according to clinical evaluation
Measured: 1 year
Weight
weight in kilograms
Measured: 1 year
Length
Length in centimeters
Measured: 1 year
Time to establish breastfeeding
Days from birth till sufficiently breastfeeding
Measured: 2 weeks
Length of hospital stay after birth
Length of hospital stay after birth
Measured: 1 month
Days to regain birthweight
Time after birth to regain birthweight
Measured: 1 month
Stool characteristics - Amount
Score from 1-4 using Amsterdam Stool Scale
Measured: 1 year
Stool characteristics - Consistency
Score from 1-6 using Diapered Infant Stool Scale
Measured: 1 year
Stool characteristics - Color
Score from 1-6 using Amsterdam Stool Scale
Measured: 1 year
Defacation frequency
Amount af defacations per week
Measured: 1 year
Full solid food
Age at which infant is no longer breastfed
Measured: 1 year
Frequency of infections
Infections per year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Apr 2022
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding PatternsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lise Aunsholt, Neonatologist, Clinical Professor
- Responsible party
- Principal investigator, Gustav Riemer Jakobsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lise Aunsholt, md, phd, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272566
- Sponsor's protocol ID
- PrePhage, Donor
- Status last verified
- May 2024
- First submitted
- 15 Feb 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Truly anonymizing data with infants recently born in a small society such as Denmark is challenging. The data may be released at a later date.
Publications
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. 2026 Feb;115(2):353-359. doi: 10.1111/apa.70333. Epub 2025 Oct 6.
PubMed 41051016
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prephage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Donor Study
- ClinicalTrials.gov ID
- NCT05272566
- Acronym / sponsor ID
- PrePhage, Donor
- Conditions
- Feeding Patterns, Microbial Colonization
- Keywords
- Microbiome, Bacteriophage, Feeding Pattern, Stool Pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lise Aunsholt, Neonatologist, Clinical Professor
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) to preterm infants is safe and tolerable. To investigate this, the investigators will recruit 20 donor infants and their mothers from time of delivery, and both will be subjected to a novel screening program including blood, urine, breastmilk, fecal screening and standard clinical investigation. Donor fecal samples will be collected from time of birth and with varying intervals for consecutive 3 years for 3 purposes: 1) to conduct safety studies in preterm piglets before transfer to preterm recipient infants, 2) to conduct FFT to preterm infants, and 3) to map normal microbiota development in healthy infants. The feces used for donation will be collected between 2-4 weeks after birth. After 1 year, donated feces will be released for FFT to preterm, but only if the donor infant at this time has been healthy and normally developed. Donors are followed up for consecutive 3 years after birth. Maternal fecal samples will be compared to infant samples, to investigate maternal to infant transfer of microbiota, as well as changes in infant microbiota in response to environment.
20 preterm infants with gestational age between 26 +0 - 30+6 weeks + days, are block randomized to either FFT or saline placebo within 24 hours after birth and the following 3 days, in total 4 donations. The recipients are clinically and biochemically closely monitored by attending staff and the group of investigators according to best clinical practice and predefined clinical observation. The recipients are followed up for consecutive 3 years to evaluate potential late side-effects and to monitor change in fecal microbiome after transplant or placebo.
The primary endpoint is to assess safety of FFT to preterm infants with expected no increase in necrotizing enterocolitis (NEC), sepsis and death in the intervention group. The secondary endpoint is to assess if, FFT treatment will reduce incidence of feeding tolerance and improve healthy gut development in recipient preterm infants. The investigators expect to find FFT safe and with fewer cases of NEC and sepsis. The investigators do not expect to prove the effect of the intervention in this study. However, the investigators aim to follow up with a double-blinded multicenter randomized control trial - powered to document our hypothesis - that when colonizing with a healthy microbiome, it is possible decrease incidence of NEC in premature infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families are recruited from out-patients clinics at the secondary level in Copenhagen
Key inclusion criteria (8 listed)
- 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.
- Women aged 18-45 and currently healthy
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut microbiome
Time frame: 1 year
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.
12 secondary outcomes
Clinical development
Time frame: 1 year
Weight
Time frame: 1 year
Length
Time frame: 1 year
Time to establish breastfeeding
Time frame: 2 weeks
Length of hospital stay after birth
Time frame: 1 month
Days to regain birthweight
Time frame: 1 month
Stool characteristics - Amount
Time frame: 1 year
Stool characteristics - Consistency
Time frame: 1 year
Stool characteristics - Color
Time frame: 1 year
Defacation frequency
Time frame: 1 year
Full solid food
Time frame: 1 year
Frequency of infections
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 41051016Kappel 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. 2026 Feb;115(2):353-359. doi: 10.1111/apa.70333. Epub 2025 Oct 6.
- Individual participant dataSharing planned: Undecided. Truly anonymizing data with infants recently born in a small society such as Denmark is challenging. The data may be released at a later date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Aunsholt, md, phd principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Patterns and Microbial Colonization, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.