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Clinical trial Recruiting at 5 sites Observational Ages 18 to 85

Checking pyloric sphincter function in people with gastroparesis symptoms

Official title: Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Run by Johns Hopkins Bloomberg School of Public Health · NCT04661215 · Data updated 2026-11-12

We will test whether EndoFLIP, a water‑load satiety test, and a gastric electrical test (Gastric Alimetry) can find pyloric sphincter abnormalities in adults with gastroparesis symptoms compared with people without symptoms.

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment150 (estimated)
SponsorJohns Hopkins Bloomberg School of Public Health
Academic / other
Locations5 sites (Scottsdale, Arizona and 4 other locations)
StatusRecruiting
StartedJanuary 13, 2026
Main results expectedMarch 30, 2027
Study endsApril 15, 2027
Registry record updatedApril 3, 2026
Trial IDNCT04661215 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–85 with gastroparesis symptoms (diabetic or idiopathic), a Gastroparesis Cardinal Symptom Index score of at least 2.0, and a 4‑hour gastric emptying study performed within the past 6 months are ideal candidates.

Probably not a fit

People without gastroparesis symptoms, those younger than 18 or older than 85, or patients who cannot stop excluded medications or complete the tests may not receive direct benefit from participation.

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

What this trial studies

This multi-center, prospective observational project enrolls adults with gastroparesis symptoms (both delayed and normal gastric emptying) and control participants without symptoms. It uses the FDA-approved EndoFLIP catheter to measure diameter, cross-sectional area, pressure, distensibility, and compliance of the lower esophageal and pyloric sphincters. Symptomatic participants will also undergo a water-load satiety test and gastric myoelectrical recording with the Gastric Alimetry system, while control participants will not receive the Gastric Alimetry testing. Measurements will be compared across symptomatic subgroups and controls to determine the prevalence and characteristics of pyloric abnormalities.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify pyloric problems and better target treatments for people with gastroparesis symptoms.

How similar studies have gone: Prior single-center work using EndoFLIP and pyloric-focused approaches has suggested pyloric dysfunction in some patients with gastroparesis, but combining EndoFLIP with Gastric Alimetry and water-load testing across multiple centers is less established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria FOR SYMPTOMATIC PARTICIPANTS:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, aged 18-85
4. Symptoms of gastroparesis, either diabetic or idiopathic etiology
5. Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0
6. Individual will have had a prior 4-hour gastric emptying scintigraphy test performed for clinical evaluation within the last 6 months. This gastric emptying test would be done for clinical evaluation and is not part of the research study. From these participants with gastroparesis symptoms, we will include those with delayed gastric emptying as well as those with normal gastric emptying.
7. Participant must not initiate any new treatments until completion of the study procedures.
8. Willingness to:

   1. Stop histamine 2 antagonists, prokinetics (e.g., metoclopramide, erythromycin, domperidone, prucalopride), narcotics, anticholinergics, constipation medications (over the counter laxatives, isotonic polyethylene glycol (PEG) electrolyte preparations (e.g. MiraLax), prescription laxatives (e.g. lubiprostone), proton pump inhibitors, cannabinoids, and cannabidiol (CBD) for 3 days prior to each visit;
   2. Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.

INCLUSION CRITERIA FOR CONTROL PARTICIPANTS

1. Provision of signed and dated informed consent form
2. Male or female, aged 18 or older
3. Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.
4. Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.

EXCLUSION CRITERIA:

1. Prior gut lumen surgery on the esophagus or the stomach, including Nissen fundoplication.
2. Prior surgery on the pylorus (G-POEM, surgical pyloroplasty, surgical pyloromyotomy)
3. Known history of achalasia or esophageal stricture
4. Known history of physiological or mechanical GI obstruction
5. Abnormalities seen on a prior upper endoscopy placing patient at increased risk:

   * Ulcer of the esophagus, stomach, or duodenum
   * Esophageal varices
6. Individuals at risk for prolonging the endoscopy procedure: severe chronic pulmonary disease, severe food retention in the stomach on endoscopy.
7. Presence of significant gastric or duodenal pathology that could be expected to cause dysmotility (e.g. significant inflammation, infiltrate disorders etc)
8. Individuals with a history of other chronic disease potentially causative of gastrointestinal symptom
9. Acute or chronic renal insufficiency
10. Current eating disorders
11. Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to endoscopic procedures.
12. Individuals with contraindications for endoscopy, including bleeding abnormalities
13. Allergy to eggs preventing sedation with propofol and/or gastric emptying test
14. Significant dysphagia
15. Prior inflammatory bowel disease, Crohn's
16. History of any esophageal/gastric/pyloric injection of botulinum toxin
17. Patients on daily opioid use or \>3 day/week use
18. Use of glucagon-like peptide 1 (GLP1) receptor agonists or Sodium-Glucose Transport Protein 2 (SGLT2); Gastric inhibitory polypeptide (GIP)- glucagon-like peptide (GLP) combo

Where it's running

  • Mayo Clinic Arizona
    Scottsdale, Arizona, United States     Recruiting
  • University of Louisville
    Louisville, Kentucky, United States     Recruiting
  • Massachusetts General
    Boston, Massachusetts, United States     Recruiting
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina, United States     Recruiting
  • Temple University
    Philadelphia, Pennsylvania, United States     Recruiting

Study contacts

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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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.