Scientists probe the mechanics of swallowing to improve diagnosis
NCT ID NCT06883175
First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time
Summary
Researchers at Northwestern University are studying how the esophagus works in people with swallowing difficulties. They will use specialized tests to measure the strength and movement of the esophageal wall, including a medication called prucalopride that affects gut movement. The goal is to find better ways to diagnose conditions like achalasia and ineffective esophageal motility, and to predict how patients will respond to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prucalopride, a medication that stimulates gut movement, plus diagnostic tests using FLIP and high-resolution manometry
- What this could lead to
- If successful, this could lead to better ways to diagnose swallowing disorders and predict which treatments will work for which patients.
- What could go wrong
- This is an observational diagnostic study, not a treatment trial, so it will not cure anyone. The new measures may not prove more useful than current tests, and prucalopride can cause side effects like headache or nausea.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 575 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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