New Study Examines Brain-Gut Relationship in
those Suffering with Stomach Pain or Discomfort (Functional Dyspepsia)
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 (NIH) at six medical centers in the U.S.
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
For information about participating in the trial, contact the
central study coordinator, Vickie Silvernail :at (507) 284-2812
or dyspepsia@mayo.edu
For general information about digestive diseases, see: http://digestive.niddk.nih.gov/ddiseases/a-z.asp
The NIDDK, a component of the NIH, conducts and supports research
in diabetes and other endocrine and metabolic diseases; digestive
diseases; nutrition, and obesity; and kidney, urologic and hematologic
diseases. For more information about NIDDK and its programs, see: www.niddk.nih.gov
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.
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