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Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

NCT04872452 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-13

No results posted yet for this study

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.

Conditions

  • Small Fiber Neuropathy
  • Gastrointestinal Dysmotility

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.

Sponsors & Collaborators

Principal Investigators

  • Pankaj J Pasricha, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872452 on ClinicalTrials.gov