NCT04208828 IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
| NCT ID | NCT04208828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Louisville |
| Condition | Gastrointestinal Motility Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-01-02 |
| Primary Completion | 2028-01-02 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
Inclusion Criteria: Patient with otherwise refractory symptoms of gastrointestinal (GI) motor disorders. \- Exclusion Criteria: Inability to receive intravenous immunoglobulin. \-