Actively Recruiting
IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
Led by University of Louisville · Updated on 2025-08-01
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates patients experiencing generalized gastrointestinal (GI) dysmotility symptoms, including gastroparesis, who do not respond to current medications, devices, or other treatments. It focuses on a subgroup with autoimmune gastrointestinal neuropathies (GAIN) or autoimmune gastrointestinal dysmotility (AGID), conditions identified by specific blood tests or organ abnormalities involving the GI tract. The study aims to observe these patients and their responses to intravenous immunoglobulin (IVIG) therapy. Patients receive IVIG therapy typically in 12-week courses using standard dosing. This observational study records clinical data from patients who meet the criteria and receive this treatment, which has shown promise for those refractory to other therapies such as diet changes, drugs, devices, or surgical interventions. The study monitors their symptoms before and after at least one course of IVIG. Participants complete a standardized patient-reported outcome survey to document their GI symptoms at the start and after IVIG treatment, with symptom scores tracked up to one year. Researchers evaluate changes in the total gastrointestinal symptom score (TSS) over time. The study collects and reviews all clinical observations without introducing new interventions or randomization, with participation lasting as long as patients continue to be observed for symptom changes.
CONDITIONS
Brief Title
IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with otherwise refractory symptoms of gastrointestinal (GI) motor disorders
- Age between 12 and 90 years
You will not qualify if you...
- Inability to receive intravenous immunoglobulin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to one year
Participants who undergo intravenous immunoglobulin (IVIG) therapy for gastrointestinal autoimmune neuropathy are observed for changes in their symptoms.
Baseline and follow-up assessments using patient reported outcome surveys
Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
T
Thomas L Abell, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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