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

Sponsor
University of Louisville (Other)
Overall Status
Recruiting
CT.gov ID
NCT04208828
Collaborator
(none)
400
Enrollment
1
Location
36
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
    Actual Study Start Date :
    Jan 2, 2020
    Anticipated Primary Completion Date :
    Jan 2, 2023
    Anticipated Study Completion Date :
    Jan 2, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Gastrointestinal (GI) total symptoms score (TSS) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    -

    Exclusion Criteria: Inability to receive intravenous immunoglobulin.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Louisville Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • University of Louisville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Abell, Professor, University of Louisville
    ClinicalTrials.gov Identifier:
    NCT04208828
    Other Study ID Numbers:
    • 15.0667
    First Posted:
    Dec 23, 2019
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Thomas Abell, Professor, University of Louisville
    Gastroparesis
    Nausea
    Vomiting
    Abdominal Pain
    Neuropathy
    Additional relevant MeSH terms:
    Gastroparesis
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Mar 31, 2022