BOSTON — A new clinical trial is underway at the Massachusetts General Hospital (MGH) to assess the safety and efficacy of the probiotic bacteria GanedenBC30 (Bacillus coagulans GBI-30, 6086) in outpatients with irritable bowel syndrome (IBS) and major depressive disorder (MDD). This research is believed to be the first of its kind to examine common factors underlying both gut and psychiatric disorders and the use of probiotics as an intervention in depression.
Researchers hypothesize that patients treated with the probiotic bacteria GanedenBC30 will have a greater improvement in specific IBS and depressive symptoms at the end of the study than those treated with placebo.
In the United States, an estimated 15 million people are affected by IBS, characterized by abdominal pain/discomfort and disturbance of bowel habits without identifiable structural abnormalities. IBS has a chronic course associated with significant disability and health care burden. Annual direct and indirect costs of IBS are between $20-$30 billion in the United States. Depression also affects an estimated 15 million people in the U.S. each year and is estimated to have direct and indirect costs of more than $34 billion. It is believed that by 2020, depression will be the second most common health problem in the world.
"There are reports of high co-occurrence of IBS and psychiatric disorders, which suggests that it is perhaps more than just coincidental," says Maurizio Fava, MD, researcher at MGH and lead investigator on the clinical trial. "Studies have shown that lifetime psychiatric co-morbidity, especially depression and anxiety, may occur in up to 70 to 90 percent of IBS patients who seek treatment."
Studies have shown a high prevalence of IBS in psychiatric patients who seek treatment. For instance, gastrointestinal symptoms are very common among patients with depression — 29 percent of these patients have been found to meet IBS criteria and 46 percent of panic disorder patients suffered from IBS. This interface of psychiatry and IBS has also contributed to understanding of IBS and its treatment, adds Fava, who says that antidepressant drugs are often used to treat IBS.
Only in the past 15 years have gastroenterologists been using psychopharmacologic agents to treat functional gastrointestinal disorders. Although conventional IBS medications, such as laxatives, antidepressants, antispasmodics, antibiotics and bulking agents, are useful for some IBS patients, patients generally are dissatisfied with their overall efficacy and tolerability creating a need for additional treatments for IBS.
Fava adds, "There are more than two dozen FDA-approved antidepressants, and we also have some natural treatments for depression including St. John’s Wort, SAMe, fish oil, and folate. But these treatments don’t work for all patients, and many come with undesirable side effects."
"Placebo-controlled studies are necessary to determine how effective it is to give probiotics to large populations of people with depression and IBS," says Dr. Fava. "However, we do know that probiotics have no harmful side effects to patients compared to other IBS and depression therapies."
The 60-day, double-blind, placebo-controlled multi-site study across primary care practices will assess the efficacy and safety of probiotic bacteria GanedenBC30 treatment in outpatients with depression and IBS. Funding for the study comes from Ganeden Biotech, which markets GanedenBC30 in its Sustenex and Digestive Advantage brands of over-the-counter probiotic products. Study completion is expected in 2011.
Individuals who wish to learn more about the study should call the MGH's Depression Clinical and Research Program at (877) 55-BLUES (552-5837) or the individual treatment sites at 781-505-8710 (Burlington), or 781-433-3026 (Charles River Medical).
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $600 million. The hospital is home to major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, photomedicine, regenerative medicine, systems biology, transplantation biology.
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