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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2020-01-02 with a primary completion date of 2028-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04208828 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 90 Years, studying Gastrointestinal Motility Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04208828 currently recruiting?
Yes, NCT04208828 is actively recruiting participants. Contact the research team at thomas.abell@louisville.edu for enrollment information.
Where is the NCT04208828 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT04208828 clinical trial?
NCT04208828 is sponsored by University of Louisville. The trial plans to enroll 400 participants.