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临床试验/NCT04506593
NCT04506593招募中不适用

Gastrointestinal Motility Diagnosis Registry

Indiana University2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
2
主要终点
Identification of patients by accurate motility diagnosis

研究概览

简要总结

Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders

详细描述

Develop a registry (list of patients) of patients seen the clinics with motility disorders. Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis will be made by physicians with specialized in GI Motility, based on clinical consensus of diagnostic criteria. The information gathered from the database will be used to help promote future clinical research in the GI motility and Neurogastroenterology Unit at Indiana University School of Medicine.

Gastrointestinal motility symptoms are very common. It encompasses a wide range of problems, such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension, weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is essential in order to promote cost-effective treatment and future research to benefit patients with GI motility disorders

Specific Aims

  1. Primary Aim: Identification of patients by accurate motility diagnosis

  2. Secondary Aims:

  3. To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)

  4. To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
  • Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table

排除标准

  • 1. Coexisting medical conditions that may limiting participation in clinical research trial

结局指标

主要结局

Identification of patients by accurate motility diagnosis

时间窗: .through study completion, an average of 10 years

Motility diagnosis will be made by physicians with specialized in GI Motility, based on consensus diagnostic criteria. The information gathered from the database will be used to help promote future clinical development and research in GI motility disorders.

次要结局

  • Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)(through study completion, an average of 10 years)
  • Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis(through study completion, an average of 10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John M. Wo

Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit

Indiana University

研究点 (2)

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