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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | Any neonate or infant up to 2 years of age scheduled for an intestinal surgery or an esophogastroduodenoscopy or colonoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of surgery for another clinical problem. |
| 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. | Within 48 hours before or after the clinically-driven surgery. |
| Fraction of Stool Microbiome that has beneficial microbes | We will collect stool samples to analyze the microbiome using bulk microbial RNA sequencing. | Within 48 hours before or after the surgery from which the biopsy is obtained. |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates or infants that are admitted to the in-patient units for intestinal intervention.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy O'Connell, MD, PhD | Contact | 617-919-1807 | Amy.OConnell@childrens.harvard.edu | |
| Kate Eident, BS | Contact | 617-355-2184 | katherine.eident@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy O'Connell, MD, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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If the patient is having an intestinal intervention:
Further, a single sample of stool will be collected either immediately before or after the procedure from the patient's diaper.