Enterocolitis, NecrotizingNCT04549727
Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC
An observational study of Enterocolitis, Necrotizing and Prematurity, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged. Read more about this study
- Who is it for?
- Ages Up to 44 weeks
- Conditions the study is for
- Enterocolitis, Necrotizing, Prematurity, Gastrointestinal Disease
- What is being tested?
- Organoids creation
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 17 Feb 2022
- 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 Up to 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Investigators will use surgically-resected intestinal samples from NEC patients and gestational age-matched non-NEC surgical controls with intestinal resection for other reasons than NEC to conduct various analysis. For comparative studies, Investigators aim to grow enteroids from intestinal tissues freshly collected from preterm and term babies with an age limit of 44 weeks of postmenstrual age (PMA). Group 1: intestinal samples from small and/or large bowel in NEC preterm and term babies. Group 2 (Control group): Age- and intestinal area-matched (small and/or large bowel) No NEC babies, which have surgical resection for other reason than NEC
Who may be able to join
- Infants, with a postconceptional age below 44 weeks of gestation, undergoing a clinically indicated intervention of partial intestinal resection while hospitalized at the NICU of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico.
Who cannot join
- Infants presenting a devastating damage of the intestine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of Neonatal Necrotizing Enterocolitis
Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged.
Investigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients
- Generate a tissue biorepository composed of: enteroids and other lamina propria cells
- Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants
- In vitro functional studies for the evaluation of critical factors in NEC pathophysiology
- In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions
- Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens
- In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants
- Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC
- Being tested
- Organoids creation
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoids creationOther
Organoids are created from discarded tissue
| Study group | Role | What they receive |
|---|---|---|
| infants with surgical NEC | Infants who undergo surgery for NEC disease Receives: Other: Organoids creation | |
| Infants with GI surgical diseases other than NEC | Infants who undergo surgery for other GI diseases than NEC Receives: Other: Organoids creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative studies of gene expression
assess the gene expression profile of tissue, epithelial enteroids and underlying lamina propria derived from NEC, non-NEC (further classified as hypoxic and non-hypoxic infants).
NB: the unit of analysis will be the organoids derived from patients' tissues Investigators expect to be able to derive 1 cell line per patient, and the number of derived organoids will depend from the viability of individual cell lines.
Measured: 2 years
functional studies barrier functionality
evaluation of barrier functionality at the baseline and in enteroids-derived monolayers challenged with pathogens, dead bacteria (as postbiotics), LPS, pharmacological agents, enteral nutrients and to evaluate innate immune response and barrier functionality as previously investigated in fetal enteroids and the contribution of myofibroblast, immune and ENS to the immune response
Measured: 2 years
functional studies on cellular death
studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions
Measured: 2 years
Correlative studies of the impact of perinatal variables
Assess how the perinatal features (expression of the neonatal phenotype, as IUGR, chorionamnionitis, perinatal hypoxia) on the intestinal barrier functionality at baseline and challenged with pathogens
Measured: 2 years
compare the intestinal barrier functionality in pathological conditions
comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants
Measured: 2 years
Validation of the enteroid NEC model
Validate the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Nov 2020 (estimated)
- Primary completion17 Feb 2022 (estimated)
- Study completion17 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterocolitis, NecrotizingStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Paola Roggero, MD PHD, Principal investigator, University of Milan Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549727
- Sponsor's protocol ID
- BIENTERNIP
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of Neonatal Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT04549727
- Acronym / sponsor ID
- BIENTERNIP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 17 Feb 2022 (estimated)
- Study completion
- 17 Feb 2022 (estimated)
- First posted
- 16 Sep 2020 (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.
Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged.
Investigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients
- Generate a tissue biorepository composed of: enteroids and other lamina propria cells
- Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants
- In vitro functional studies for the evaluation of critical factors in NEC pathophysiology
- In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions
- Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens
- In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants
- Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infants with surgical NEC | – | Other: Organoids creationInfants who undergo surgery for NEC disease |
| Infants with GI surgical diseases other than NEC | – | Other: Organoids creationInfants who undergo surgery for other GI diseases than NEC |
Who may qualify
- Ages
- Up to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Investigators will use surgically-resected intestinal samples from NEC patients and gestational age-matched non-NEC surgical controls with intestinal resection for other reasons than NEC to conduct various analysis. For comparative studies, Investigators aim to grow enteroids from intestinal tissues freshly collected from preterm and term babies with an age limit of 44 weeks of postmenstrual age (PMA). Group 1: intestinal samples from small and/or large bowel in NEC preterm and term babies. Group 2 (Control group): Age- and intestinal area-matched (small and/or large bowel) No NEC babies, which have surgical resection for other reason than NEC
Key inclusion criteria (1 listed)
- Infants, with a postconceptional age below 44 weeks of gestation, undergoing a clinically indicated intervention of partial intestinal resection while hospitalized at the NICU of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico.
Key exclusion criteria (1 listed)
- Infants presenting a devastating damage of the intestine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoids creationOrganoids are created from discarded tissue | Other | Infants with GI surgical diseases other than NEC, infants with surgical NEC |
Primary outcome
Comparative studies of gene expression
Time frame: 2 years
assess the gene expression profile of tissue, epithelial enteroids and underlying lamina propria derived from NEC, non-NEC (further classified as hypoxic and non-hypoxic infants). NB: the unit of analysis will be the organoids derived from patients' tissues Investigators expect to be able to derive 1 cell line per patient, and the number of derived organoids will depend from the viability of individual cell lines.
functional studies barrier functionality
Time frame: 2 years
evaluation of barrier functionality at the baseline and in enteroids-derived monolayers challenged with pathogens, dead bacteria (as postbiotics), LPS, pharmacological agents, enteral nutrients and to evaluate innate immune response and barrier functionality as previously investigated in fetal enteroids and the contribution of myofibroblast, immune and ENS to the immune response
functional studies on cellular death
Time frame: 2 years
studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions
Correlative studies of the impact of perinatal variables
Time frame: 2 years
Assess how the perinatal features (expression of the neonatal phenotype, as IUGR, chorionamnionitis, perinatal hypoxia) on the intestinal barrier functionality at baseline and challenged with pathogens
compare the intestinal barrier functionality in pathological conditions
Time frame: 2 years
comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants
Validation of the enteroid NEC model
Time frame: 2 years
Validate the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Paola Roggero, MD PHD principal investigator
University of Milan Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Questions about this trial
What is this clinical trial studying?
An observational study of Enterocolitis, Necrotizing and Prematurity, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Roggero, MD PHD (+393472777054, paola.roggero@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative studies of gene expression (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2020.