跳至主要内容
临床试验/NCT04872439
NCT04872439进行中(未招募)不适用

Novel Antineuronal Antibodies in Gastrointestinal Motility Disorders

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Antibodies for Autoimmune Gastrointestinal Dysmotility

研究概览

简要总结

Gastrointestinal motility disorders represent a heterogeneous group of neuromuscular diseases of the enteric nervous systems. While autoimmune neuromuscular diseases of the central nervous system (CNS) are well described, the role of autoimmunity in enteric nervous system (ENS) has been less studied. Approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system proteins, suggesting an autoimmune mechanism targeting the enteric nervous system. The investigator's aim is to identify novel anti neuronal antibodies that contribute to autoimmune gastrointestinal motility disorders by analyzing the serum of patients with abnormal gastrointestinal motility.

详细描述

Autoimmune gastrointestinal dysmotility (AGID) represents a subset of autoimmune disorders that affect the motor function of the gastrointestinal tract. It will often result in refractory gastrointestinal symptoms and poor quality of life. Approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system gangliosides and glycoproteins, which may be suggestive of an autoimmune mechanism targeting the enteric nervous system. The diagnosis is often made clinically in patients with gastrointestinal dysmotility in the context of primary autoimmune disease or a paraneoplastic syndrome. To date, specific diagnostic tests for AGID disorders do not exist. This study will aim to find whether patients with symptomatic autoimmune gastrointestinal dysmotility (AGID) will have a specific antigen and/or antibody causing the symptoms. The study will also aim to find whether patients with positive autoantibody titers will frequently have positive tilt-table testing (autonomic dysfunction).

The goal of this study is to determine the prevalence of autoimmune antibodies in patients presenting with unexplained GI dysmotility and refractory symptoms, and to examine the outcome (safety, tolerability, and clinical improvement) in a pilot cohort of such patients with a serum screening for antigens, antibodies, and validated questionnaires. This will be a prospective pilot study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Males and females >13 years old.
  • Patient referred to the GI Motility clinic for suspected enteric dysmotility based on chronic refractory gastrointestinal symptoms
  • English proficiency and literacy sufficient to sign consent.

排除标准

  • Pregnancy documented with a serum or urine pregnancy test. If participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine test for pregnancy and remove them from the study if the test results come back positive.

研究组 & 干预措施

Antibody isolation, DNA isolation

Patients with GI dysmotility

干预措施: Blood sample collection (Diagnostic Test)

结局指标

主要结局

Antibodies for Autoimmune Gastrointestinal Dysmotility

时间窗: Baseline

Presence or absence of Autoimmune Gastrointestinal Dysmotility specific antibodies.

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 (1)

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