Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT04894656
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18-75 years old).
* Men and women.
* Patients with gastroparesis.
Exclusion Criteria:
* Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori.
* Patients with uncontrolled diabetes mellitus (hemoglobin A1C \> 10).
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months.
* Patients currently prescribed aspirin or aspirin regimens for other clinical reasons.
* Patients with known allergies to lactulose: mannitol will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04894656
Study Brief:
Protocol Section:
NCT04894656