Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Not Applicable

Withdrawn

• Conditions: Small Fiber Neuropathy; Gastrointestinal Dysmotility
• Interventions: Procedure: Skin biopsy

• Registration Number: NCT04872452
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Study Start: 2023-12-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy participants	Skin biopsy	-
Gastrointestinal dysmotility participants	Skin biopsy	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States