A new clinical study will explore the brain-gut interaction in patients with functional dyspepsia and whether certain drugs can effectively relieve symptoms of this disorder. Functional dyspepsia is a costly and chronic disorder that can cause severe stomach pain often reported as cramping, bloating and gas, or great discomfort or fullness after eating. The study is funded by the National Institutes of Health at six medical centers in the US.
The Functional Dyspepsia Treatment Trial (FDTT) will determine if either of two FDA-approved drugs that act on both the brain and the gut are better than placebo in relieving stomach pain, or discomfort after meals, in patients with functional dyspepsia. The study will also determine whether certain genes can predict who will best respond or not respond to the medicines. Finally, the trial will determine whether participants have a continued response for six months after the medicines are stopped.
Functional dyspepsia is a commonly diagnosed disorder. The symptoms are thought to be the result of abnormal muscle activity within the stomach, which may be caused by abnormal sensitivity of the nerves in the stomach or irregular signals from the brain to the muscles in the gut. “While we do not know the exact cause of functional dyspepsia, we do know that the disorder can cause chronic and sometimes debilitating symptoms that can have a dramatic effect on the quality of life for functional dyspepsia suffers,” said Patricia Robuck, Ph.D., M.P.H., project scientist for FDTT and director of the Clinical Trials Program of the Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the sponsor of the FDTT at NIH. “We are interested in learning more about the brain-gut interaction and physiological effects of these two similar but different classes of drugs on the symptoms associated with functional dyspepsia.”
Currently, the treatment of functional dyspepsia is considered limited. Standard treatment includes food restriction and antisecretory drugs (H2 blockers, proton pump inhibitors) and prokinetics, which help make the stomach empty faster. Patients with dyspepsia sometimes also try alternative medicines and non-drug measures such as hypnotherapy. The effectiveness of these alternative measures remains unproven.
Results from small studies using medications like amitriptyline and escitalopram for adults with functional dyspepsia suggest that the abdominal pain and motility may get better. “We are excited by these early findings,” says Nicholas J. Talley, M.D., Ph.D., chair of the trial and Chair of the Department of Internal Medicine at the Mayo Clinic, Jacksonville, Florida. “If it turns out that these drugs correct stomach emptying, stomach retention, and overall motility, we could help improve the quality of health and life for the millions of people with functional dyspepsia.”
Over the next five years, researchers will enroll 400 men and women, ages 18-75 years old with functional dyspepsia who have failed to respond to antisecretory treatments for the disorder. The participants will receive amitriptyline, or escitalopram, or placebo. Patients with peptic ulcer disease, a history of drug or alcohol abuse, and past abdominal surgeries will be excluded from the trial. Women who are pregnant and patients whose reading skills are insufficient to complete self report questionnaires will also be excluded. Recruitment for the trial began in January, 2007.
The following principal investigators and clinical centers are conducting the study:
Dr. Nicholas J. Talley, Mayo Clinic, Jacksonville, Florida (Study Chair) Dr. John K. Dibaise, Mayo Clinic, Scottsdale, Arizona Dr. Earnest P. Bouras, Mayo Clinic, Jacksonville, Florida Dr. G. Richard Locke, Mayo Clinic, Rochester, Minnesota Dr. Michael P. Jones, Northwestern University, Chicago, Illinois Dr. Charlene M. Prather, Saint Louis University School of Medicine, Saint Louis, Missouri Dr. Brian E. Lacy, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire