IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

Gastroparesis Clinical Trial

— GAIN  

Official title:

IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208828
• Other study ID #: 15.0667
• Status: Recruiting
• Start date: January 2, 2020
• Est. completion date: January 2, 2026

Study information

• Verified date: April 2024
• Source: University of Louisville
• Contact: Thomas L Abell, MD
• Phone: (502)852-6991
• Email: thomas.abell[@]louisville.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2, 2026
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 90 Years

Eligibility

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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Related Conditions & MeSH terms

• Gastrointestinal Motility Disorder
• Gastroparesis
• Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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