Mark Smith of OpenBiome: Should Scientists Step Up to Supervise Patients Who Self-Administer Fecal Microbiota Transplants?

Dr. Mark Smith is a postdoctoral associate at Massachusetts Institute of Technology and co-founder of OpenBiome, a nonprofit organization focused on expanding safe access to fecal microbiota transplantation (FMT).

Smith attended the Fourth Gut Summit in Barcelona on March 14th and 15th, 2015. (See replays of the event here.) After the summit, he answered some questions for GMFH editors about a recent provocative opinion piece on FMT.

Dr. Mark Smith, co-founder of OpenBiome

Dr. Mark Smith, co-founder of OpenBiome

How much variation do you see in the way FMT is administered in different places?

There is considerable variation in the mode of delivery for FMT. The primary difference lies in the route of administration. Depending on the condition of the patient and the preferences of the treating physician, material can be delivered through the upper gastrointestinal [GI] tract or the lower GI. Upper GI administration is typically achieved through a naso-duodenal, naso-jejunal or naso-gastric tube. Lower GI administration is typically achieved through colonoscopy, sigmoidoscopy or enema. It is also possible to deliver FMT via oral capsules. We have developed an approach to encapsulation that we are completing validation with now and plan to make available later this spring.

In a recent blog post, medical journalist David Wild highlighted the urgency of addressing self-administered FMT, saying, “FMT anarchy is a problem from a public health perspective”.

Wild called for scientists to take on the role of supervising patients who self-administer FMT for indications other than C. difficile, until better data are available to guide clinicians. (Read the original post here.)

 

What do you think of this idea?

I strongly agree with the concerns expressed over the dangers of unsupervised at home therapy. OpenBiome was started largely to provide an alternative to this approach after a friend performed an at-home FMT out of desperation to treat his C. difficile infection [CDI]. I think it is important for patients to be engaged in the process and see that clinical trials are being conducted to learn whether FMT could benefit them. I can also see the logic in harm minimization through provision of access to screened healthy donors. However, given the balance of risks and benefits at this point, I would not support this approach. Instead, I think it’s important to engage with the media and the public to communicate the need for caution in this field as we approach new indications. There is an enthusiasm for projecting the success of FMT in CDI onto other indications, but the mechanism is likely quite different and the efficacy is very unlikely to be as high.

How can FMT be used appropriately and effectively going forward?

At this point, FMT should only be used in general medical practice for the treatment of recurrent C. difficile infections. This is the only indication that FMT has been shown to work for. For every other disease we still lack evidence. We need to do early phase I and phase II safety studies followed by large randomized controlled studies in order to assess [new] indications. Although the short term safety profile of FMT is favorable, given the unknown long-term implications, to ensure a positive risk-benefit ratio, we should not use FMT for other indications until we have assembled evidence that it can be an effective therapy.

 

For more expert opinion on FMT, see here:

A GUIDE TO THE PRESENT AND FUTURE OF FECAL MICROBIOTA TRANSPLANTATION, WITH DR. ALEXANDER KHORUTS

Kristina Campbell
Kristina Campbell
Science writer Kristina Campbell (M.Sc.), from British Columbia (Canada), specializes in communicating about the gut microbiota, digestive health, and nutrition. Author of the best selling Well-Fed Microbiome Cookbook, her freelance work has appeared in publications around the world. Kristina joined the Gut Microbiota for Health publishing team in 2014.  Find her on: GoogleTwitter