The Innervation of Human Gut Sensory Epithelial Cells

NCT02888587 | Completed

• 1 other identifier: Pro00075870
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study has two objectives:

1. 1.To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts from human tissue to produce organoids. These organoids will be used to study the biology of innervated sensory epithelial cells.
2. 2.to collect subject data relating to clinical management and demographic characteristics of patients undergoing upper endoscopy or colonoscopy to learn the mechanisms behind visceral hypersensitivity, and neurodegenerative diseases that may arise in the gut.

Conditions

Organoids

Outcome Measures

Primary Outcomes (1)

• Expression of sensory receptors in enteroendocrine cells

  Organoids are expected to contain enteroendocrine cells. We will use electrophysiology to measure the electrical excitability of these cells. In enteroendocrine cells from patients with a visceral hypersensitivity diagnosis is expected that cells will fire action potentials at a significantly lower threshold. These results will be correlated with RNA sequencing analysis to study the expression of sensory receptors in enteroendocrine cells.

  4 years

Study Arms (2)

Control group

no gastrointestinal symptoms

Symptomatic group

Patients with Visceral hypersensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified as they are seen by the GI group during scheduled appointments, laboratory tests or endoscopic or operative procedures. All patients undergoing either endoscopy OR colonoscopy OR both procedures will be eligible for inclusion in this study

You may qualify if:

• adult males and females 18 years of age or older who have been seen by the GI clinic or who have been scheduled for direct-to-procedure appointment in the GI clinic.

You may not qualify if:

• Subjects who are not competent to give consent
• Males and females under 18 years of age
• Women who are pregnant

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

To obtain endoscopic and colonoscopic biopsies to harvest and culture intestinal crypts from human tissue to produce organoids. These organoids will be used to study the biology of innervated sensory epithelial cells.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: September 5, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)