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Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Primary Purpose

Small Fiber Neuropathy, Gastrointestinal Dysmotility

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin biopsy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Small Fiber Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Gastrointestinal dysmotility participants

Healthy participants

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 30, 2021
Last Updated
February 3, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04872452
Brief Title
Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders
Official Title
Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 22, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Fiber Neuropathy, Gastrointestinal Dysmotility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastrointestinal dysmotility participants
Arm Type
Experimental
Arm Title
Healthy participants
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of small fiber neuropathy in skin biopsy samples
Description
Presence or absence of small fiber neuropathy obtained after the skin biopsy procedure.
Time Frame
Only one biopsy but analysis may take one year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pankaj J Pasricha, MD
Phone
4105506766
Email
pasricha@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo A Barahona, MD
Phone
4106038343
Email
gbaraho1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankaj J Pasricha, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

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