A Study to Understand the day-to-day Variability in Stomach Emptying and Gastrointestinal (GI) Transit in Patients with Digestive Symptoms

Overview

About this study

The purpose of this study is to understand the day-to-day variability in stomach emptying and gastrointestinal (GI) transit in patients with digestive symptoms. This information will be useful for interpreting the results of stomach emptying studies in future.

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:

  1. People with upper GI symptoms (e.g., due to functional dyspepsia or diabetes mellitus)
  2. Able to provide written informed consent before participating in the study
  3. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

  1. Severe nausea or vomiting, which may preclude study assessments
  2. 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 were not discontinued within 4 half-lives prior to either (i.e., clinical or research) scintigraphy. See the attached pdf file of the clinical protocol for a comprehensive list of medications that interfere with GI transit.
  3. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study.  History of or ongoing inflammatory bowel disease (e.g, Crohn’s disease or ulcerative colitis). However, participants with microscopic or collagenous colitis will be eligible to participate
  4. Prior gastric or major intestinal (i.e., resection of > 50 cm) or colonic surgery (i.e., hemi or subtotal colectomy)
  5. Participants who are allergic to eggs or decline to consume milk
  6. History of radiation therapy to the abdomen
  7. Positive pregnancy test

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adil Bharucha, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Bridget Neja

(507)538-3883

Neja.Bridget@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-20314306

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