Recruiting

IVIG

Sponsor:

University of Louisville

Code:

NCT04208828

Conditions

Gastrointestinal Motility Disorder

Gastroparesis

Neuropathy

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04208828

Start date

Jan 2, 2020

Status verified date

Jul, 2025

Completion date

Jan 2, 2028

Anticipated

Primary completion date

Jan 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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

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Exclusion Criteria: Inability to receive intravenous immunoglobulin.

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Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

More Information

Sponsor

University of Louisville

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • Gastroparesis
  • Nausea
  • Vomiting
  • Abdominal Pain
  • Neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-08-01.