Study of Normal Intestinal Development and Disease in Premature and Term Neonates (NCT06681129) | Clinical Trial Compass
RecruitingNot Applicable
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
United States100 participantsStarted 2025-03-17
Plain-language 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).
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of intestinal stem cells and mature epithelial cells
Timeframe: At the time of surgery for another clinical problem.
2
Degree of Immune System Changes
Timeframe: Within 48 hours before or after the clinically-driven surgery.
3
Fraction of Stool Microbiome that has beneficial microbes
Timeframe: Within 48 hours before or after the surgery from which the biopsy is obtained.