IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

NCT ID: NCT04208828

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2028-01-02

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.

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.

Conditions

Gastrointestinal Motility Disorder; Gastroparesis; Neuropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Thomas Abell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Thomas L Abell, MD

Role: CONTACT

thomas.abell@louisville.edu

(502)852-6991

Facility Contacts

Thomas L Abell

Role: primary

thomas.abell@louisville.edu

(502)852-6991

Other Identifiers

15.0667

Identifier Type: -

Identifier Source: org_study_id