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NCT Number: NCT06681129

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

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).

Recruiting

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Key information

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Amy O'Connell, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of intestinal stem cells and mature epithelial cells

    Time frame: 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.

  2. Degree of Immune System Changes

    Time frame: 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.

  3. Fraction of Stool Microbiome that has beneficial microbes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy O'Connell, MD, PhD

CONTACT

[email protected]

617-919-1807

Kate Eident, BS

CONTACT

[email protected]

617-355-2184

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Study of Normal Intestinal Development and Disease in Premature and Term Neonates - a Pathway for the Study of Premature and Neonatal Intestinal Disorders Including the Roles of Nutrition, Microbes, and Cellular Physiology, and Diseases Including Necrotizing Enterocolitis

Acronym: NiiCE

Important dates

Study start
2025
Primary completion
2031
Study completion
2034
First posted
Nov 8, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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