IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT04208828
Status
Recruiting
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Conditions

  • Gastrointestinal Motility Disorder
  • Gastroparesis
  • Neuropathy

Eligibility Criteria

Sex
ALL
Age
12 Years - 90 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 2, 2020
Status verified
Jul 2025
Primary completion
Jan 2, 2028
Completion
Jan 2, 2028

Study Design

Enrollment
400 participants (estimated)

Primary Outcome Measure

Gastrointestinal (GI) total symptoms score (TSS) [ Time Frame: Baseline to latest, up to one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Thomas L Abell
[email protected]
(502)852-6991

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By research site
University of Louisville· Louisville, KY

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