Study of Normal Intestinal Development and Disease in Premature and Term Neonates
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 2
SponsorBoston Children's Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.
Disqualifiers
Children > 2 years of age.
Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.
Trial population
Neonates or infants that are admitted to the in-patient units for intestinal intervention.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Neonates
Trial outcomes
Primary outcomes
1
Number of intestinal stem cells and mature epithelial cells
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.
Time frame
At the time of surgery for another clinical problem.2
Degree of Immune System Changes
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.
Time frame
Within 48 hours before or after the clinically-driven surgery.3
Fraction of Stool Microbiome that has beneficial microbes
We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing.
Time frame
Within 48 hours before or after the surgery from which the biopsy is obtained.Sponsors and contacts
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Source ClinicalTrials.gov