Clinical trial for vibrating capsule for chronic constipation underway

Participating hospitals nationwide are currently enrolling patients in a clinical trial to test a new vibrating capsule for patients with chronic constipation, according to a Temple University Hospital press release.

“Chronic constipation is a very common problem in the United States and many people do not get good relief with current treatments available,” Ron Schey, MD, FACG, associate professor of medicine at Temple University School of Medicine, associate director of the Gastrointestinal Motility and Esophageal Program at Temple University Hospital, and trial investigator, said in the release. “Although their symptoms may be alleviated somewhat with the use of laxatives, they may still feel that they need some more treatment or that they would like to explore other options. We are pleased to be able to offer this enhanced option to our patients.”

This randomized, double-blind trial aims to determine the efficacy of this tiny, motorized capsule in alleviating constipation. Participants will be randomly assigned to receive two capsules per week for 8 weeks or placebo, and will record in a diary the frequency and completeness of bowel movements, abdominal pain, straining, and when they took the capsules, the release said. Including a 2 week preparation period and a 2 week follow-up period, each patient will participate in the trial for a total of 12 weeks.

The device is programmed to begin vibrating 6 to 8 hours after being swallowed, which is the average amount of time it takes to travel to the large intestine, according to the release. The stimulation provided by the device has been demonstrated to produce intestinal contractions and help move stool through the GI tract.

Temple University Hospital is currently pre-screening patients for the trial, which is sponsored by Vibrant Ltd., the capsule manufacturer.