Improving understanding and treatment of swallowing difficulties
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
This study is testing how well a new treatment can help people with swallowing difficulties and related symptoms by looking at how their esophagus works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 575 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06883175 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the understanding of dysphagia and related esophageal disorders by investigating the relationship between intrabolus pressure and esophagogastric junction compliance. It will involve both standard diagnostic tests and innovative research procedures on participants presenting with swallowing difficulties, regurgitation, or related symptoms. The study will include a cohort of 375 subjects, with a subset receiving treatment with prucalopride to assess its effects on esophageal function. The goal is to refine the classification of esophageal motor disorders and improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with complaints of dysphagia, regurgitation, chest pain, or food impaction.
Not a fit: Patients with active severe esophagitis or those currently participating in another clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic and treatment strategies for patients suffering from dysphagia and related conditions.
How similar studies have performed: Previous studies have shown promise in understanding esophageal motility disorders, but this approach aims to bridge gaps in current knowledge, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The source of the study population will be male and female subjects aged 18-85 years old inclusive (females of childbearing potential should be on highly effective contraceptive methods) and mentally capable to provide informed consent who present to the Northwestern Medicine Digestive Health Center with the chief complaint of dysphagia, regurgitation, chest pain or food impaction, or referral for treatment of achalasia, GERD, scleroderma, or endoscopy negative dysphagia. All subjects must be able to undergo endoscopy with functional lumen imaging probe (FLIP) and transnasal intubation for 4 dimensional-High Resolution Manometry (4D HRM) and 24-hour pH impedance probe. Exclusion Criteria: * Currently participating in a concurrent clinical trial or completed another trial within past 8 weeks. * Active severe esophagitis (Los Angeles esophagitis Grade C and above), Patients may be eligible once esophagitis is healed if they continue to have dysphagia in the context of healed esophagitis. Contact PD/PI: Pandolfino, John Erik Protection of Human Subjects Page 131 * Evidence of mechanical obstruction due to stricture (e.g., peptic/GERD patients, EoE, or other) or previous small bowel or colonic obstruction. * Long-segment Barrett's metaplasia. * Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included. EKG will be performed before prucalopride in the 60 patients undergoing Experiment 1a. * Current drug or alcohol abuse or dependency. * Current neurologic or cognitive impairment which would make the patient an unsuitable candidate for a research trial. * Severe mental illness, e.g., uncontrolled major depression with suicidal ideation, active psychosis, diagnosis of schizophrenia-spectrum disorder. * Pregnant patients. * Bleeding diathesis or need for anticoagulation that cannot be stopped for endoscopy.
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: John E Pandolfino, MD
- Email: j-pandolfino@northwestern.edu
- Phone: 3126950182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.