Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
SUMMARY

The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Male or female, aged 18-85

• Symptoms of gastroparesis, either diabetic or idiopathic etiology

• Symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0 (18/45 x 5)

• 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.

• Participant must not initiate any new treatments until completion of the study procedures.

• Willingness to:

‣ 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;

⁃ Abstain from food and water after midnight (at least for 8 hours) before the start of each visit until after the visit.

• Provision of signed and dated informed consent form

• Male or female, aged 18 or older

• Undergoing an upper endoscopy for their clinical evaluation of diarrhea, GI bleed, or iron-deficiency anemia, or evaluation for bariatric surgery.

• Do not have upper GI symptoms greater than 1 as assessed by the Gastroparesis Cardinal Symptom Index (GCSI) of PAGI-SYM questionnaire.

Locations
United States
Arizona
Mayo Clinic Arizona
NOT_YET_RECRUITING
Scottsdale
Kentucky
University of Louisville
RECRUITING
Louisville
Massachusetts
Massachusetts General
NOT_YET_RECRUITING
Boston
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Pennsylvania
Temple University
RECRUITING
Philadelphia
Texas
Texas Tech University Health Science Center (TTUHSC)
NOT_YET_RECRUITING
El Paso
Contact Information
Primary
Laura A Miriel, BS
laura.miriel@jhu.edu
410-955-4165
Backup
Emily Mitchell, MS, MBA
esharke5@jhu.edu
Time Frame
Start Date: 2025-12-28
Estimated Completion Date: 2027-04
Participants
Target number of participants: 150
Treatments
Symptoms of gastroparesis
Participants with symptoms of gastroparesis with minimum Gastroparesis Cardinal Symptom Index (GCSI) score of 2.0 (18/45 x 5)
Control participants
Participants undergoing endoscopy for evaluation but without gastroparesis symptoms or gastroesophageal reflux symptoms. Score 1.0 or less (≤ 1 ) on the GCSI of Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) questionnaire
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Temple University, University of Louisville, Massachusetts General Hospital, Texas Tech University Health Sciences Center, El Paso, Wake Forest University
Leads: Johns Hopkins Bloomberg School of Public Health

This content was sourced from clinicaltrials.gov