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

NCT06681129 | Recruiting

• 1 other identifier: IRB-P00033538
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

NEC; Early Intestinal Development; Intestinal Intervention; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (3)

• Number of intestinal stem cells and mature epithelial cells

  Small intestinal biopsy specimens will be collected either from discarded surgical biopsies collected for clinical reasons or from 1-2 additional small bunch biopsies (5mm) near the surgery site. The tissue will be used to 1.) generate organoids for longitudinal cell culture, 2.) analyze RNA or protein components by transcriptomic or cellular analyses or 3.) analyze histology. We do not have discrete planned outcomes because this is an investigational study and we are looking for new trends or differences.

  At the time of surgery for another clinical problem.

• Degree of Immune System Changes

  We will collect a small 1 tsp amount of blood (5mL) and use this to analyze immune cell types or cytokines in the blood. These will include monocytes, T cell, B cells, and neutrophils for the cell types. Cytokines will include IL-1, IL-2, IL-3, IL-4, Il-5, IL-6, Il-8, IL10, IL-13, IL-22, IL-33, TNFa, IFNg, IFNa, MCP1, MIP1a.

  Within 48 hours before or after the clinically-driven surgery.

• Fraction of Stool Microbiome that has beneficial microbes

  We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing.

  Within 48 hours before or after the surgery from which the biopsy is obtained.

Study Arms (1)

Neonates

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

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates or infants that are admitted to the in-patient units for intestinal intervention.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

If the patient is having an intestinal intervention: 1. Those having a surgery that involves a resection of tissue: a portion of the tissue will be collected for research. A blood draw (\~1mL) will occur as well, only if another clinical blood draw is ordered at that time. 2. For those patients having a biopsy with no tissue resected: one or two additional small tissue biopsies will be collected. Further, a single sample of stool will be collected either immediately before or after the procedure from the patient's diaper.

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Intestinal Diseases

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Amy O'Connell, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy O'Connell, MD, PhD

CONTACT

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

Kate Eident, BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician in Medicine, Division of Newborn Medicine; Director of Infection Control, Neonatal ICU; Faculty, Neonatal Genomics Program

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: November 8, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)