Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Tsinghua Chang Gung Hospital

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

Treatment groups

120 Participants
are divided into 4 treatment groups