Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Johns Hopkins University

Status: Withdrawn

Conditions: Small Fiber Neuropathy; Gastrointestinal Dysmotility

Treatments: Procedure: Skin biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04872452

IRB00146085

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Gastrointestinal dysmotility participants

Experimental group

Treatment:

Procedure: Skin biopsy

Healthy participants

Other group

Treatment:

Procedure: Skin biopsy