Understanding Intestinal Development and Disease in Infants
This study is looking at how the intestines develop normally in babies and how intestinal diseases, like necrotizing enterocolitis (NEC), affect them. Researchers want to understand more about human intestinal development because most current research uses mice, which aren't always the best comparison for humans. This is an observational study, meaning you wouldn't receive any new treatments. Instead, researchers would collect information from babies up to 2 years old who are already having intestinal surgery or biopsies. They will measure things like the number of certain cells in the intestine, changes in the immune system, and the types of good bacteria in stool samples. The goal is to improve our overall understanding of these important areas. The study plans to enroll 100 participants, but its current status is unclear.
- Study design
- This is an observational study, meaning no new treatments are given. It aims to enroll 100 participants.
- What's involved
- Participation involves providing intestinal tissue samples during a planned surgery or biopsy, and a stool sample within 48 hours of that procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Amy O'Connell, MD, PhD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of intestinal stem cells and mature epithelial cellsAt 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 ChangesWithin 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 microbesWithin 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.