Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Sponsor

Johns Hopkins University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04872452

Collaborator

(none)

Enrollment

Location

Arms

41.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Fiber Neuropathy Gastrointestinal Dysmotility	Procedure: Skin biopsy	N/A

Detailed Description

Gather basic, clinical information and perform small 3-6mm skin biopsies.
Identify characteristics of epidermal nerve fibers in patients with symptoms of gastrointestinal dysmotility
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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Anticipated Study Start Date :

Aug 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gastrointestinal dysmotility participants	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.
Other: Healthy participants	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.

Arm

Intervention/Treatment

Experimental: Gastrointestinal dysmotility participants

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.

Other: Healthy participants

Procedure: Skin biopsy

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Pankaj J Pasricha, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04872452

Other Study ID Numbers:

IRB00146085

First Posted:

May 4, 2021

Last Update Posted:

Apr 8, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Small Fiber Neuropathy

Study Results

No Results Posted as of Apr 8, 2022