Integrated Assessment of Gastric Functions

Overview

About this study

The purpose of this study is to investigate, in a cohort of healthy people and patients who are experiencing upper gastrointestinal symptoms, whether gastric emptying scintigraphy can be modified to evaluate both gastric emptying, gastric antral motility and the symptomatic response to feeding, in a single non-invasive test.

 

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Healthy Volunteers:

  • Male and female volunteers aged 18-80 years old.
  • No significant medical conditions or gastrointestinal symptoms by interview or questionnaire:
    • 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.

Inclusion Criteria - Patients:

  • Male and female volunteers aged 18-80 years.
  • 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.

Exclusion Criteria - Healthy Volunteers and Symptomatic Patients: 

  • 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.
  • 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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Xiao Jing Wang, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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