IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

NCT04208828 | Recruiting

• 1 other identifier: 15.0667
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Motility Disorder; Gastroparesis; Neuropathy

Keywords

Gastroparesis; Nausea; Vomiting; Abdominal Pain; Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting; Abdominal Pain

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pain

Central Study Contacts

Thomas L Abell, MD

CONTACT

(502)852-6991; thomas.abell@louisville.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 2, 2020
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)