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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis; Neuropathy; Gastrointestinal Motility Disorder

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Thomas L Abell, MD; Phone Number: (502)852-6991; Email: thomas.abell@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Thomas L Abell; Phone Number: 502-852-6991; Email: thomas.abell@louisville.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• 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.

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal (GI) total symptoms score (TSS)	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	Baseline to latest, up to one year

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Estimated): January 2, 2026
• Study Completion (Estimated): January 2, 2026

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Abdominal Pain; Nausea; Vomiting; Neuropathy; Gastroparesis
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Neuromuscular Diseases; Paralysis; Peripheral Nervous System Diseases; Gastroparesis
• Other Study ID Numbers: 15.0667

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No