Improving understanding and treatment of swallowing difficulties

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: John E Pandolfino, MD
• Email: j-pandolfino@northwestern.edu
• Phone: 3126950182

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Masseter and Thigh Muscle Ultrasound to Predict Dysphagia and Sarcopenia in Critically Ill Adults

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• Effects of CTAR and a Swallowing Pressure Ball in Older Stroke Adults

  This study tests whether home-based CTAR exercises plus a swallowing pressure ball can improve swallowing function and eating-related quality of life for older adults who had a stroke and have dysphagia.

  Recruiting Chimei Medical Center · Tainan, Tainan City · NCT07620210

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.