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Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC

NCT04549727 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2020-09-17

No results posted yet for this study

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.

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

1. Generate a tissue biorepository composed of: enteroids and other lamina propria cells
2. Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants
3. In vitro functional studies for the evaluation of critical factors in NEC pathophysiology
4. In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions
5. Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens
6. In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants
7. Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC

Conditions

  • Enterocolitis, Necrotizing
  • Prematurity
  • Gastrointestinal Disease

Interventions

OTHER

Organoids creation

Organoids are created from discarded tissue

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Paola Roggero, MD PHD · University of Milan Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Eligibility

Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-02-17
Completion
2022-02-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549727 on ClinicalTrials.gov