IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy (GAIN)
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|ClinicalTrials.gov Identifier: NCT04208828|
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 18, 2020
|Condition or disease|
|Gastrointestinal Motility Disorder Gastroparesis Neuropathy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy|
|Actual Study Start Date :||January 2, 2020|
|Estimated Primary Completion Date :||January 2, 2023|
|Estimated Study Completion Date :||January 2, 2023|
- Gastrointestinal (GI) total symptoms score (TSS) [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208828
|Contact: Thomas L Abell, MD||(502)email@example.com|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Thomas L Abell 502-852-6991 firstname.lastname@example.org|