Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT06681129

Conditions

NEC

Necrotizing Enterocolitis

Intestinal Disease

Human Development

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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).

Conditions

NEC

Necrotizing Enterocolitis

Intestinal Disease

Human Development

Study ID

NCT06681129

Start date

Mar 17, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Sep 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.

Exclusion Criteria:

  • Children > 2 years of age.
  • Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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. ]
  • Degree of Immune System Changes [ Time Frame: Within 48 hours before or after the clinically-driven surgery. ]
  • Fraction of Stool Microbiome that has beneficial microbes [ Time Frame: Within 48 hours before or after the surgery from which the biopsy is obtained. ]

Central Contacts and Locations

Central contacts

Amy O'Connell, MD, PhD

617-919-1807Amy.OConnell@childrens.harvard.edu

Kate Eident, BS

617-355-2184katherine.eident@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • NEC
  • Early Intestinal Development
  • Intestinal Intervention
  • Necrotizing Enterocolitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-27.