A Study to Assess Gastric Functions

Overview

About this study

The purposes of this study are to assess gastric motility and emptying with scintigraphy in patients with upper gastrointestinal symptoms, to evaluate the relationship between daily symptoms and GE, motility, and symptoms during a GE study, to assess fasting and postprandial gastric volumes and motility with MRI in patients with upper gastrointestinal symptoms, and to compare gastric motility measured with scintigraphy and MRI.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Male and female volunteers aged 18-80 years old.
  • Persistent upper gastrointestinal symptoms (nausea, vomting, bloating, post prandial fullness or post prandial pain) for > 6 months.
  • Having capacity to provide written informed consent before participating in the study.
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
  • Undergoing a clinically indicated a gastric emptying study or having completed a gastric emptying study.

Exclusion Criteria:

  • Severe nausea or vomiting, which may preclude study assessments.
  • Use of medications that, in the opinion of the investigator have the potential, to alter GI motility (e.g., narcotics, medications with significant anticholinergic effects, prokinetic agents) and which cannot be discontinued for 4 half-lives prior to the imaging studies.
  • Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.  A history of inflammatory bowel disease (e.g, Crohn’s disease or ulcerative colitis).  However, participants with microscopic or collagenous colitis will be eligible to participate.
  • Prior gastric or major intestinal (i.e., resection of > 50 cm) or colonic surgery (i.e., hemi or subtotal colectomy).  Appendectomy, cholecystectomy, tubal ligation,  hysterectomy, herniorrhaphy, and limited colonic resection are permissible.
  • Participants who are allergic to eggs or decline to consume milk.
  • History of radiation therapy to the abdomen.
  • Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire 11.
  • Contraindications for MR imaging: i.e. pacemakers, aneurysm clips, cochlear implants.*
  • Pregnant women, breast-feeding women, prisoners and institutionalized individuals.*
  • Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain.
  • Positive tissue transglutaminase antibodies (TTG).
  • Poor peripheral venous access, if central venous access is not available.
  • Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Prichard, M.B., B.Ch., Ph.D.

Open for enrollment

Contact information:

David Prichard M.B., B.Ch., Ph.D.

(507)284-6808

Prichard.David@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20463727

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