IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

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.

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Key information

Conditions

Gastrointestinal Motility Disorder Abdominal Pain Digestive System Diseases Gastrointestinal Diseases Gastroparesis Nausea Neurologic Manifestations Neuropathy Pain Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Vomiting

Age range

12 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Thomas L Abell

CONTACT

[email protected]

(502)852-6991

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Inability to receive intravenous immunoglobulin.

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas L Abell, MD

CONTACT

[email protected]

(502)852-6991

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Acronym: GAIN

Important dates

Study start: 2020
Primary completion: 2028
Study completion: 2028
First posted: Dec 23, 2019
Registry last updated: Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed