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Clinical Trials/NCT04872452
NCT04872452
Withdrawn
Not Applicable

Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Johns Hopkins University1 site in 1 countryDecember 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Small Fiber Neuropathy
Sponsor
Johns Hopkins University
Locations
1
Primary Endpoint
Presence of small fiber neuropathy in skin biopsy samples
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 22, 2023
End Date
January 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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