Actively Recruiting
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
Led by Boston Children's Hospital · Updated on 2026-03-27
100
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Research on early intestinal development often uses mouse models, but these do not perfectly match human development since timing and key proteins differ. This study aims to better understand important parts of intestinal growth in human babies, focusing especially on conditions like necrotizing enterocolitis (NEC) that occur early in life. The goal is to gain insights that mouse studies cannot provide. The study involves observing neonates and infants up to 2 years old who are scheduled for intestinal surgery or procedures like esophogastroduodenoscopy or colonoscopy that include biopsies. Researchers will examine tissue samples and stool collected around the time of these clinical procedures to study cells in the intestine, immune system changes, and beneficial microbes in the gut. Participants will be monitored during their clinically required procedures, with data collected at or near the time of surgery or biopsy. The main outcomes include counting intestinal stem and mature cells, assessing immune system changes within 48 hours before or after surgery, and measuring beneficial microbes in stool samples taken around surgery. The study continues until December 2034, with no extra treatments involved, focusing on observation and sample analysis.
CONDITIONS
Brief Title
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates or infants up to 2 years old who are scheduled for intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy or colonoscopy.
You will not qualify if you...
- Children older than 2 years.
- Infants 0-2 years old not undergoing gastrointestinal surgery or intestinal scope with biopsy procedure.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At the time of clinically-driven surgery or biopsy procedure
Participants undergo scheduled intestinal surgery or intestinal biopsies from esophogastroduodenoscopy or colonoscopy for clinical reasons, during which samples are collected for study purposes.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed to study intestinal development and disease progression up to 2 years of age after surgery or biopsy.
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Amy O'Connell, MD, PhD
K
Kate Eident, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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