Effect of Cholecystokinin (CCK) on Gastroduodenal Activity in Humans

Overview

About this study

The purpose of this research study to compare the effects a hormone cholecystokinin (CCK) in the bloodstream in healthy people and in patients with rapid gastric emptying. CCK regulates (controls) the rate at which food empties from the stomach into the small intestine. We want to learn how CCK affects the activity of the stomach and small intestines in patients with rapid gastric emptying. We are also trying to learn if genes regulate the effects of CCK.

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:

Controls

  • Healthy male volunteers
  • Non-pregnant, non-breastfeeding female volunteers
  • 18-70 years old
  • Able 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

Additional inclusion criteria for patients

  • Symptoms of dyspepsia with rapid gastric emptying by scintigraphy

Exclusion Criteria:

Patients and controls

  • Abdominal surgery other than appendectomy, cholecystectomy, tubal ligation or hysterectomy
  • Clinical evidence of significant:
    • Ccardiovascular 
    • Respiratory 
    • Renal 
    • Hepatic 
    • Gastrointestinal
    • Hematological 
    • Neurological 
    • Psychiatric 
    • Other disease that may interfere with the objectives of the study and/or pose safety concerns 
  • Medications that may alter gastrointestinal motility, e.g., antipressants, alpha adrenergic agonists, calcium channel or b blockers. 
  • Stable dose of thyroxine will be permitted. 
  • If it is clinically safe, antidepressants (e.g., nortrptyline, amitryptyline), which are often used at low doses to delay gastric emptying and/or reduce visceral sensitivity, will be discontinued in patients before the study
  • Patients who have taken any investigational medications within the past 30 days
  • Pregnant or breast-feeding females

Exclusion criteria for controls only

  • Current symptoms of a functional gastrointestinal disorder assessed by questionnaire

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.

Open for enrollment

Contact information:

Kelly Feuerhak CCRP

(507)255-6802

Feuerhak.Kelly@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-20313594

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