Jan 31 2015
Chronic constipation is a common problem that affects approximately 15 percent of the U.S. population, according to the American Gastroenterological Association. It can be painful and lead to a reduction in a patient's quality of life. Temple University Hospital is the only hospital in the Philadelphia region participating in a nationwide clinical trial to test an innovative, vibrating capsule for patients with chronic constipation.
The randomized, double-blind trial is investigating whether the non-drug therapy can help alleviate constipation. The non-drug, non-secreting treatment involves the use of a tiny, motorized capsule that is programmed to start vibrating six to eight hours after being swallowed. This is the average amount of time that it takes the capsule to travel from the stomach to the large intestine. The stimulation caused by the vibrating capsule has been shown to produce contractions in the intestine, which helps move stool through the digestive tract efficiently.
Ron Schey, MD, FACG, Associate Professor of Medicine at Temple University School of Medicine, and Associate Director of the Gastrointestinal Motility and Esophageal Program at Temple University Hospital, is the local principal investigator in the trial. "Chronic constipation is a very common problem in the United States and many people do not get good relief with current treatments available," said Dr. Schey. "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."
Patients who meet the clinical criteria for participation in the trial will be randomized into two groups with half of them receiving the vibrating capsules and the other half receiving a placebo. They will all swallow two capsules a week for 8 weeks. Patients are required to keep diaries where they will record information on bowel movement frequency and completeness, abdominal pain, straining during bowel movement and the dates and times that they take the capsules.
Each patient will take part in the trial for a total of 12 weeks, which includes a two week preparation and two week follow-up period. Researchers will analyze whether patients who received the vibrating capsule experienced an increase in spontaneous bowel movements and a reduction in symptoms.
Temple is currently pre-screening patients for the trial. Interested individuals may call Lavette Dibble, Clinical Research Coordinator, at 215-707-9900, for more information.
Source:
Temple University Health System