Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Small Fiber Neuropathy Clinical Trial

Official title:

Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04872452
• Other study ID #: IRB00146085
• Status: Withdrawn
• Phase: N/A
• Start date: December 22, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Dysmotility
• Small Fiber Neuropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.