Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04872452

Enrollment

Registered

2021-05-04

Start date

2023-12-22

Completion date

2026-01-31

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Dysmotility, Small Fiber Neuropathy

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

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.

Interventions

PROCEDURESkin 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026