A Study of the Effect of the Vibrant Capsule on Gastric Emptying and Motility in Healthy Volunteers

Overview

About this study

The Vibrant Capsule is a novel vibrating device for the treatment of gastrointestinal disorders. The effect of different vibrations on the motor functions of the gastrointestinal tract are unclear. The study will focus on the stomach in healthy volunteers. The study will compare the effects of Vibrant Capsule treatment and a sham capsule treatment on gastric emptying and gastric motility in healthy volunteers.

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

  • Able to provide written informed consent prior to any study procedures, and willing and able to comply with study procedures
  • No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
  • Body mass index of 18-35 kg/m2
  • Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure
  • For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study
  • Female subjects unable to bear children must have this documented in the medical record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)]

Exclusion Criteria

  • Unable or unwilling to provide informed consent or to comply with study procedures
  • Diagnosis of gastrointestinal diseases
  • Structural or metabolic diseases that affect the gastrointestinal system
  • Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study
    • Medications that alter gastrointestinal transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin
    • Analgesic drugs including Nonsteroidal Anti-Inflammatory Drugs and COX-2 inhibitors 
      • Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible
  • History of recent surgery (within 60 days of screening)
  • Acute or chronic illness or history of illness which, in the opinion of the investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
  • Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator
  • Acute gastrointestinal illness within 48 hours of initiation of the baseline period
  • Females who are pregnant or breastfeeding
  • History of excessive alcohol use or substance abuse
  • Participation in an investigational study within the 30 days prior to dosing in the present study
  • Any other reason, which in the opinion of the investigator, would confound proper interpretation

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

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-20201663

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