An observational study in Gastrointestinal Motility Disorder, Gastroparesis and Neuropathy, sponsored by University of Louisville. Recruiting at 1 site in United States. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by University of Louisville · Observational
Among 184 studies in Gastroparesis with a site in United States — 35 open to participants now, 43 under way, 2 of them phase 3. Gastroparesis · United States.
Among the 184 studies in Gastroparesis with a site in United States, this one is the 10th largest by planned enrollment of the 39 observational ones, is one of 12 that started in 2020, is one of 39 observational ones, reaches primary completion later than 28 of the 40 other live ones, and was the 115th registered.
323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 80 observational studies indexed under Gastroparesis.
Browse Gastroparesis studies →35 of the 184 studies in Gastroparesis with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 50 Gastroparesis studies recruiting now, 25 (50%) set no upper age limit and 15 (30%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.
This study: 12 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →184 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 12 started in 2020.
Median enrollment 36 across the 136 interventional studies, 108 across the 39 observational. Of the 124 that completed or were terminated, 63 (51%) have results posted.
55 of 184 have an industry lead sponsor. The 10 most frequent:
University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
University of Louisville has 6 studies filed under Gastroparesis — fewer than ten, so there is no comparison to draw.
14 of the studies in Gastroparesis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01696734Phase 3M.D. Anderson Cancer CenterDomperidone in Treating Patients With Gastrointestinal Disorders | 2027-10-31 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06046833Samita GargContinuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes | 2026-12 |
| NCT02165059Indiana UniversityGI Neuromuscular Pathology Prospective Registry | 2026-12 |
| NCT04282317Indiana UniversityMagnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis | 2026-12-31 |
Among the 184 studies in Gastroparesis with a site in United States, from their registry updates:
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.
Gastrointestinal dysmotility disorders encompass a large group of patients including a subset with autoimmune findings, either on serologic testing and/or end organ anatomic and physiologic effects.
The identification of patients with autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), has led to trial with autoimmune therapies. Most promising therapy has been intravenous immunoglobulin (IVIG) and this, usually given in 12-week courses with standard dosing, has helped a number of patient's refractory to other available therapies including diet, drugs, devices and enteral diversions/disruptions.This observational study documents clinical observations in consecutive patients meeting entry criteria who received IVIG.
Patients will have their gastrointestinal (GI) symptoms documented by a standardized patient reported outcome (PRO) survey at baseline and use the same assessment tools after at least one course of IVIG therapy.
Patients with GI motor disorders, including symptoms of gastroparesis, who are refractory to available dietary, drug, device, and endoscopic/surgical diversion therapies.
Inclusion Criteria: Patient with otherwise symptoms of gastrointestinal (GI) motor disorders.
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Exclusion Criteria: Inability to receive intravenous immunoglobulin.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gastrointestinal (GI) total symptoms score (TSS)
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
Time frame: Baseline to latest, up to one year
Started Jan 2020 (actual). Primary completion is estimated for Jan 2028, 96 months after the start.
How these figures are worked out, and which studies are left out of them.
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