Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

NCT04872452 | Withdrawn

• 1 other identifier: IRB00146085
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Fiber Neuropathy; Gastrointestinal Dysmotility

Outcome Measures

Primary Outcomes (1)

• Presence of small fiber neuropathy in skin biopsy samples

  Presence or absence of small fiber neuropathy obtained after the skin biopsy procedure.

  Only one biopsy but analysis may take one year.

Study Arms (2)

Gastrointestinal dysmotility participants

EXPERIMENTAL

Procedure: Skin biopsy

Healthy participants

OTHER

Procedure: Skin biopsy

Interventions

Skin biopsy PROCEDURE

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.

Gastrointestinal dysmotility participants; Healthy participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Pankaj J Pasricha, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 4, 2021
• Study Start: December 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (1)