SAN DIEGO — Gastroenterologists must work to protect desperate patients who are susceptible to unproven treatments such as fecal microbiota transplantation, a speaker said here.
“We need to be thinking as scientists as well as clinicians and to a phased approach to using this in the future,” David T. Rubin, MD, FACG, co-director, Inflammatory Bowel Disease Center, University of Chicago Medicine, said while delivering his portion of the American Journal of Gastroenterology Lecture during the American College of Gastroenterology Annual Scientific Meeting. Rubin was joined by Stephen M. Collins, MBBS, department of medicine, McMaster University in Hamilton, Ontario, in giving the lecture on the emerging role of the microbiome in the pathogenesis and management of inflammatory bowel disease.
David T. Rubin
Rubin broke down his suggested approach into three research phases for fecal microbiota transplantation (FMT). Phase 1 includes studying the safety and feasibility, including translational outcomes. Phase 2 would refine the approach by analyzing dose ranging and would include longer-term follow-up. Phase 3 would involve controlled trials.
At present, there have been promising case reports and case series reports regarding FMT, predominantly in ulcerative colitis, but there have been no controlled trials, Rubin said. There also have been only a few attempts to accurately describe the impact of FMT on a patient’s microbiome.
The positive results, however, have created considerable enthusiasm among patients desperate for an answer to their IBD concerns despite the FDA’s ruling that an investigational new drug application is needed to use FMT for IBD, Rubin said.
With so many questions currently regarding why the treatment doesn’t work in all cases, Rubin suggested caution and the need to listen to patients and develop a trusting relationship.
“We’re just learning,” Rubin said at a press conference after the lecture. “We need to be thoughtful and careful.”