跳至主要内容
临床试验/NCT04872452
NCT04872452撤回不适用

Analysis of Cutaneous Nerve Biopsies in Gastrointestinal Motility Disorders

Johns Hopkins University2 个研究点 分布在 1 个国家开始时间: 2023年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Presence of small fiber neuropathy in skin biopsy samples

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Presence of small fiber neuropathy in skin biopsy samples

时间窗: Only one biopsy but analysis may take one year.

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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