Research Yielding New Insights into the Emerging Therapy of Fecal Microbiota Transplant

Fecal microbiota transplants appear safe and patients tolerate them well in trials, but the evidence isn’t there yet to establish overall benefit for treating ulcerative colitis according to David Rubin, MD, Professor of Medicine, Section Chief, Gastroenterology, Hepatology and Nutrition, and Co-Director of the Inflammatory Bowel Disease Center at University of Chicago Medicine.

Though fecal microbiota transplant treatments for inflammatory bowel disease (IBD) are currently in phase 1, 2, and 3 trials, there are many remaining challenges in the field.

Among them is the recognition that though most people group inflammatory bowel disease into ulcerative colitis or Crohn’s disease, there are more than 100 kinds of IBD, Rubin said Monday during a session at Digestive Disease Week 2014 in Chicago, IL. Microbiota in the gut are different geographically as well, even among people who move from place to place in the US.

Misunderstandings also surround IBD. Determining whether it is driven more by genetics or environment in each patient and knowing what therapies patients have been exposed to is important in moving ahead clinically.

“We need to understand who we are testing and who we’re treating,” Rubin said.

It does appear that FMT for IBD is safe in the short term, he said. In the long-term, there has been some onset of new diagnoses.

“We have to be careful of that. Basically we’re concerned that transplantation of multiple things beyond organisms and proteins and antibodies from donors may predispose recipients to susceptibleconditions that may express themselves.”

So why have some treatments failed? Rubin says more research is needed on confounders such as dietary factors and whether recipients are smokers or ex-smokers. Researchers may also need to take a look at the donors.

Is it wrong to use a parent, child or family member who lives in the same household? Should the donor follow a particular diet — gluten-free, for example—for better results? Should we be testing the microbiota of the donors? Should the patient be allowed to choose the donor?

Using bacterial combinations from fecal matter has been used for more than 50 years to treat gastrointestinal disease. These treatments have been thought of as last-ditch efforts to relieve patients with the most severe intestinal infections.

Unanswered questions are frustrating for patients as well as clinicians. “Patients want this now,” Rubin said. They see it as a natural therapy and there’s a perception that it must be safe.

With FMT, a donor stool sample is mixed with salt water and filtered to remove particulates. It can be administered to the recipient through a colonoscope, as an enema, or through a naso-gastric tube.

A profileration of misinformation on the Internet has added to patients’ confusion and fears. “The desperate patient is the one that most needs our protection,” Rubin says.