Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers

Study Overview
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Brief Summary
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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 Sham capsule treatment on gastric emptying and gastric motility in healthy volunteers.

Official Title
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Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study

Conditions
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Gastroparesis

Intervention / Treatment
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* Device: Sham vibrating capsule
* Device: Vibrant Capsule (1 vibration)
* Device: Vibrant Capsule (3 vibration)
* Device: Vibrant Capsule (5 vibration)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide written informed consent prior to any study procedures, and be 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 NOTE: 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 of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham vibrating capsule<br>Sham vibrating capsule | Device: Sham vibrating capsule<br>* Sham device without vibration<br>|
| Active Comparator: Vibrant Capsule (1 vibration)<br>1 vibration/min | Device: Vibrant Capsule (1 vibration)<br>* 1 vibration/min<br>|
| Active Comparator: Vibrant Capsule (3 vibration)<br>3 vibrations/min | Device: Vibrant Capsule (3 vibration)<br>* 3 vibration/min<br>|
| Active Comparator: Vibrant Capsule (5 vibration)<br>5 vibrations/min | Device: Vibrant Capsule (5 vibration)<br>* 5 vibration/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroduodenal manometry measurement of first hour postprandial distal antral motility index. |  | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying of solids:T1/2 in minutes (scintigraphy) |  | 5 hours | 
| Gastric emptying of solids: lag time in minutes (scintigraphy) |  | 5 hours | 
| Gastric emptying at 1h (scintigraphy) |  | 1 hour | 
| Gastric emptying at 2h (scintigraphy) |  | 2 hours | 
| First 0.5h postprandial distal antral motility index (Gastroduodenal manometry) |  | 30 minutes | 
| Abdominal Symptom assessments - VAS |  | 5 hours |