Mayo Clinic announced that it has enrolled the first patient in a phase one study of a unfrozen oral capsule formulated to treat Clostridium difficile infection.
The capsule is formulated to rehabilitate the human gut microbioby delivering a broad spectrum of live microbes into the patient's intestinal tract. The gut microbiome hosts trillions of microbes that live in harmony with their human host and perform processes vital for health.
"New therapies are urgently needed to prevent recurrent C-diff, a debilitating, costly and potentially life-threatening infection," says Sahil Khanna, M.B.B.S., a gastroenterologist at Mayo Clinic and principal investigator on the study. He says the study will enroll approximately 20 patients in a prospective, two-arm, phase-one, safety assessment and dosing study at Mayo Clinic's Rochester campus.
"C-diff infections are an increasingly difficult-to-resolve intestinal infection that cause about 29,000 deaths annually in the U.S.," says Dr. Khanna.
Dr. Khanna says potential advantages to providing an oral capsule for treatment that is stable at room temperature include flexibility in dosing and at-home treatment. Currently, patients seeking treatment must travel to a medical center for a fecal transplant procedure that involves the placement of live microbes into the patient's body in a procedure similar to a colonoscopy.
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