NCT04872452

Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is being done to evaluate cutaneous nerve biopsies from patients with refractory gastrointestinal motility disorders. The purpose of the study is to evaluate skin biopsies for signs of small fiber neuropathy in GI dysmotility patients, which may provide a better understanding of the underlying pathology of their condition. Specifically, identifying any small fiber neuropathy that may exist in the peripheral nervous system may help us to better understand the mechanism of presumed enteric neuropathy that may be involved in causing GI dysmotility.

Detailed description

1. Gather basic, clinical information and perform small 3-6mm skin biopsies. 2. Identify characteristics of epidermal nerve fibers in patients with symptoms of gastrointestinal dysmotility 3. To isolate skin-derived precursor cells from skin biopsies and test their ability to generate neurons in vitro and in immune-deficient mouse models.

Conditions

• Small Fiber Neuropathy
• Gastrointestinal Dysmotility

Interventions

Type	Name	Description
PROCEDURE	Skin biopsy	Any combination of the following six 3-6mm skin biopsies may be taken: palm, dorsum of hand, calf, other non-genital and non-face (this last one includes areas for use as negative controls which are not on the distal limbs). No more than 6 biopsies will be taken at one time.The biopsy size 3-6mm and method (punch, shave or wedge) will be done depending on the biologic assay destined for the biopsy. While 3mm will be sufficient for microarray analysis, 6mm will be required for any cell sorting preceding microarray analysis.

Timeline

• Start date: 2023-12-22
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2021-05-04
• Last updated: 2023-11-13

Locations

1 site across 1 country: United States