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Understanding Swallowing Difficulties: Chicago Classification Study

This study aims to better understand swallowing difficulties (dysphagia) and related conditions like achalasia and ineffective esophageal motility. Researchers are using diagnostic tests like Functional Lumen Impedance Planimetry (FLIP) and High Resolution Manometry (HRM) to learn more about how your esophagus works. Some participants will also receive prucalopride, a medication, for two weeks. The study is looking for 575 participants, aged 18 to 85, who experience symptoms like difficulty swallowing, regurgitation, or chest pain. Success will be measured by changes in your swallowing symptoms, as reported on a questionnaire, and by measuring the diameter of your esophagogastric junction (the connection between your esophagus and stomach). The current recruitment status is unclear.

Study design
This interventional study plans to enroll 575 participants and does not use randomization. A small group of 60 participants will receive prucalopride in an open-label manner.
What's involved
Participants will undergo standard diagnostic tests and complete questionnaires at the beginning of the study and again 6 months after treatment. Some participants will take prucalopride for 2 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your swallowing symptoms will be assessed at 6 months after treatment.

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NCT06883175

Evolution of the Chicago Classification: Bridging Physiology and Mechanics

Recruiting
NAAges 18–85InterventionalDiagnostic
Northwestern University
~575 participants
Updated 2025-08-11 on ClinicalTrials.gov
What's tested:FLIPHRMPrucalopride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brief Esophageal Dysphagia Questionnaire (BEDQ)
Measured over baseline
+13 more outcomes measured

Conditions

Dysphagia
Achalasia, Esophageal
Ineffective Esophageal Motility

Explore related trials

AchalasiaDysphagiaGastroesophageal Reflux DiseaseIneffective esophageal peristalsisScleroderma

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

John E Pandolfino, MD
[email protected]
3126950182
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Brief Esophageal Dysphagia Questionnaire (BEDQ)baseline

    A 10 item dysphagia/food impaction questionnaire measured on a 6-point Likert scale from "none" to "severe" with higher scores indicating a greater degree of dysphagia

  • Brief Esophageal Dysphagia Questionnaire (BEDQ)6 months post-treatment

    A 10 item dysphagia/food impaction questionnaire measured on a 6-point Likert scale from "none" to "severe" with higher scores indicating a greater degree of dysphagia

  • Esophagogastric Junction (EGJ) diameterbaseline

    Measurement of EGJ diameter in cm

  • Esophagogastric Junction (EGJ) diameter6 months post-treatment

    Measurement of EGJ diameter in cm

  • Esophageal Clearancebaseline

    Barium column height of 0 cm at 5 minutes

  • Esophageal Clearance6 months post-treatment

    Barium column height of 0 cm at 5 minutes

  • recoilbaseline

    decrease in wall diameter \>1cm

  • recoil6 months post-treatment

    decrease in wall diameter \>1cm

  • Timed Barium Esophagram (TBE) Column Heightbaseline

    Height of barium column at 5 minutes (Timed Barium Esophagram)

  • Timed Barium Esophagram (TBE) Column Height6 months post-treatment

    Height of barium column at 5 minutes (Timed Barium Esophagram)

  • Integrated Relaxation Pressure (IRP)baseline

    Mean EGJ pressure for 4 seconds of relaxation in the ten-second window following deglutitive Upper Esophageal Sphincter relaxation relaxation.

  • Integrated Relaxation Pressure (IRP)6 months post-treatment

    Mean EGJ pressure for 4 seconds of relaxation in the ten-second window following deglutitive Upper Esophageal Sphincter relaxation

  • Esophagogastric Junction Distensibility Indexbaseline

    A measure of the distensibility of the EGJ using Functional Luminal Impedance Probe

  • Esophagogastric Junction Distensibility Index6 months post-treatment

    A measure of the distensibility of the EGJ using Functional Luminal Impedance Probe