IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Gastrointestinal (GI) total symptoms score (TSS)
研究概览
简要总结
Patients with the symptoms of generalized GI dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ Some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily involving the GI tract. These disorders have been known as autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), among other terms. Some patients respond to intravenous immunoglobulin (IVIG) and this study, which is an observational clinical series, documents the patients, their findings and standardized responses to therapy with IVIG.
详细描述
Gastrointestinal dysmotility disorders encompass a large group of patients including a subset with autoimmune findings, either on serologic testing and/or end organ anatomic and physiologic effects.
The identification of patients with autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), has led to trial with autoimmune therapies. Most promising therapy has been intravenous immunoglobulin (IVIG) and this, usually given in 12-week courses with standard dosing, has helped a number of patient's refractory to other available therapies including diet, drugs, devices and enteral diversions/disruptions.This observational study documents clinical observations in consecutive patients meeting entry criteria who received IVIG.
Patients will have their gastrointestinal (GI) symptoms documented by a standardized patient reported outcome (PRO) survey at baseline and use the same assessment tools after at least one course of IVIG therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with otherwise refractory symptoms of gastrointestinal (GI) motor disorders.
排除标准
- •Inability to receive intravenous immunoglobulin.
结局指标
主要结局
Gastrointestinal (GI) total symptoms score (TSS)
时间窗: Baseline to latest, up to one year
The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia/Early Satiety, Bloating/distension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20
次要结局
未报告次要终点
研究者
Thomas Abell
Professor
University of Louisville