Observational Study of IVIG for Gastrointestinal Auto-Immune Neuropathy

This study is looking at how intravenous immunoglobulin (IVIG) affects people with severe gastrointestinal (GI) motility disorders, like gastroparesis, that haven't responded to other treatments. Some people with these conditions have an autoimmune problem affecting their GI tract, sometimes called autoimmune gastrointestinal neuropathies (GAIN) or autoimmune gastrointestinal dysmotility (AGID). This observational study will document how patients who receive IVIG respond to the treatment. You might be able to join if you are between 12 and 90 years old and have GI motor disorder symptoms that haven't improved with other therapies. The study will measure success by tracking changes in your total GI symptoms score over up to one year. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and record what happens to patients who receive IVIG. It plans to include 400 participants.
What's involved
You would have your GI symptoms documented using a standardized survey at the beginning of the study and again after at least one course of IVIG therapy.
Compensation
Not stated in the trial record.
Follow-up
Your GI symptoms will be measured from the start of the study up to one year later.

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NCT04208828

IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy

Recruiting
Not specifiedAges 12–90Observational
University of Louisville
~400 participants
Updated 2025-08-01 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gastrointestinal (GI) total symptoms score (TSS)
Measured over Baseline to latest, up to one year
Gastrointestinal Motility Disorder
Gastroparesis
Neuropathy
1 sites across 1 states
Kentucky1

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  • Gastrointestinal (GI) total symptoms score (TSS)Baseline to latest, up to one year

    The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia/Early Satiety, Bloating/distension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20