DIY FMT Q&A with Dr. Colleen Kelly

What do we know about the scope of “Do it yourself” (DIY) fecal microbiota transplant (FMT)?

We know that it is being done, but not much more than that. There are YouTube videos with thousands of views and guide-books that provide instruction in how to do it. Online communities in which people share protocols suggest that DIY FMT is not uncommonly being done. I have had patients admit to me that they have done FMT (or plan to do an FMT) on themselves or a family member, and I’m sure other patients have done it but are afraid to admit it to their doctors. There has NEVER been a study on DIY FMT.

What does the FDA say about FMT?

The FDA considers FMT a “biologic drug,” which falls under their jurisdiction to regulate. Normally this would mean that any FMT being done by doctors would be strictly overseen by the FDA. However, the FDA announced in 2013 that for cases of Clostridium difficile (C. diff) infection which isn’t responding to standard therapies, it is permissible for doctors to provide FMT without going through the agency. FMT providers must give an appropriate informed consent to patients which acknowledges that FMT is considered “experimental.” All other potential applications of FMT are strictly regulated and it is not permissible for doctors to offer their patients FMT for other conditions at this time unless it is within the confines of a clinical trial.  There are a number of clinical trials going on looking at whether FMT may be effective for other conditions such as inflammatory bowel disease and obesity; all of these research trials being done in the United States require investigators to involve the FDA.

Why is it important to understand DIY FMT?

We need to know WHY people are doing this. Do they have C. difficile but have not been able to identify a doctor to treat them? Are they unable to afford medical care? Are they hopeful that FMT will help another condition for which FMT is still experimental? Have there been beneficial effects people are experiencing after FMT that we doctors aren’t hearing about? This survey will help doctors identify areas of need for future studies. Importantly, we want to know how are people identifying and screening donors…is DIY FMT being done safely? Have people experienced side effects or infections that we aren’t hearing about?

How is this research project unique?

We have engaged collaboratively with patient advocates and are utilizing social media platforms to reach “citizen scientists,” people who want to share their experience with DIY-FMT. These shared experiences will be the FIRST data systematically collected on DIY-FMT. We hope the results of this endeavor give us insight into the scope of DIY-FMT in the United States and elsewhere. We plan to share the results later this year at medical meetings and in a medical journal, where others may learn and benefit from them.

How can I help?

If you have done a fecal transplant on yourself or someone else (family member/friend), please visit tiny.cc/DIYFMT to take the survey and tell us about it. It is completely anonymous and takes less than three minutes to complete. Then keep an eye out for the results and be proud that your participation helped make the study a success.