(Philadelphia, PA) - 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.
The trial is sponsored by Vibrant Ltd., which manufactures the capsule.
Editor's Note: Neither Dr. Schey nor any member of his immediate family has financial interest in Vibrant Ltd.
About Temple Health
Temple University Health System (TUHS) is a $1.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the "Best Hospitals" in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with Temple University School of Medicine.
Temple University School of Medicine (TUSM), established in 1901, is one of the nation's leading medical schools. Each year, the School of Medicine educates approximately 840 medical students and 140 graduate students. Based on its level of funding from the National Institutes of Health, Temple University School of Medicine is the second-highest ranked medical school in Philadelphia and the third-highest in the Commonwealth of Pennsylvania. According to U.S. News & World Report, TUSM is among the top 10 most applied-to medical schools in the nation.
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