About this trial
This is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.
Eligibility criteria
Qualifiers
Straining during more than one-fourth (25%) of defecations;
Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations;
Sensation of incomplete evacuation more than one-fourth (25%) of defecations;
Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations;
Disqualifiers
People who are not eligible for surgery or refuse to undergo any abdominal surgery.
People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
People allergic to polymeric materials.
People implanted with cardiac pacemakers and using gastrointestinal pacemakers.
Trial design
Treatments tested in this trial
- Vibrabot capsules twice a week
- Vibrabot capsules three times a week
- Vibrabot capsules five times a week
- Vibrabot capsules loading dose