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

Not yet recruiting

• Conditions: NEC; Necrotizing Enterocolitis; Intestinal Disease; Human Development

• Registration Number: NCT06681129
• Lead Sponsor: Boston Children's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-02
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Study Start: 2025-01-01
• Primary Completion: 2031-09-01
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of intestinal stem cells and mature epithelial cells	At the time of surgery for another clinical problem.	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.
Degree of Immune System Changes	Within 48 hours before or after the clinically-driven surgery.	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.
Fraction of Stool Microbiome that has beneficial microbes	Within 48 hours before or after the surgery from which the biopsy is obtained.	We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing.