Study of Normal Intestinal Development and Disease in Premature and Term Neonates

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06681129
Status
Recruiting
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Conditions

  • Human Development
  • Intestinal Disease
  • NEC
  • Necrotizing Enterocolitis

Eligibility Criteria

Sex
ALL
Age
N/A - 2 Years
Healthy Volunteers
Not accepted

Study Details

Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs between the two species. Further, prior research has demonstrated that some proteins and pathways that are critical in human development have no clear role in mice. This study aims to improve the overall understanding of critical aspects of intestinal development in humans. In addition, this study will investigate the impact of intestinal diseases that are found in the early stages of life such as necrotizing enterocolitis (NEC).

Key Dates

Start date
Mar 17, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2031
Completion
Dec 31, 2034

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Neonates
    Any neonate or infant up to 2 years of age scheduled for an intestinal surgery or an esophogastroduodenoscopy or colonoscopy.

Primary Outcome Measure

Number of intestinal stem cells and mature epithelial cells [ Time Frame: At the time of surgery for another clinical problem. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Amy O'Connell, MD

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