Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Gastrointestinal dysmotility participants
  • Other: Healthy participants

Clinical Trial Outcome Measures

Primary Measures

  • Presence of small fiber neuropathy in skin biopsy samples
    • Time Frame: Only one biopsy but analysis may take one year.
    • Presence or absence of small fiber neuropathy obtained after the skin biopsy procedure.

Participating in This Clinical Trial

Inclusion Criteria

  • Individual with a gastrointestinal motility disorder that has failed both clinical and surgical options for symptomatic management Exclusion Criteria:

  • Child 17 years of age or younger – Individuals incapable of informed consent – Patient with diseased skin or on drugs which affect skin biology.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pankaj J Pasricha, MD, Principal Investigator, Johns Hopkins University
  • Overall Contact(s)
    • Pankaj J Pasricha, MD, 4105506766, pasricha@jhu.edu

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