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IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy (GAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208828
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Abell, University of Louisville

Brief Summary:
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.

Condition or disease
Gastrointestinal Motility Disorder Gastroparesis Neuropathy

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with GI motor disorders, including symptoms of gastroparesis, who are refractory to available dietary, drug, device, and endoscopic/surgical diversion therapies.
Criteria

Inclusion Criteria: Patient with otherwise refractory symptoms of gastrointestinal (GI) motor disorders.

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Exclusion Criteria: Inability to receive intravenous immunoglobulin.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208828


Contacts
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Contact: Thomas L Abell, MD (502)852-6991 thomas.abell@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Thomas L Abell    502-852-6991    thomas.abell@louisville.edu   
Sponsors and Collaborators
University of Louisville
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Responsible Party: Thomas Abell, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT04208828    
Other Study ID Numbers: 15.0667
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Abell, University of Louisville:
Gastroparesis
Nausea
Vomiting
Abdominal Pain
Neuropathy
Additional relevant MeSH terms:
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Gastroparesis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms