FDA tightens rules for stool banks and fecal microbiota transplants

Signal of change / FDA tightens rules for stool banks and fecal microbiota transplants

By Juliette Aplin / 04 Oct 2016

The FDA (US Food and Drug Administration) has released draft legislation making it harder for doctors to use donated stool samples from non-for-profit stool banks in fecal transplants (also known as fecal microbiota transplantation, or FMT) – in which gut bacteria are transferred from a healthy person into an another patient’s intestines, in the hope of improving their ability to tackle infections.

The FDA has placed greater disease-screening and testing requirements on stool samples, as the recent regulations consider samples from donor banks as ‘investigational new pharmaceutical drug’, rather than a natural substance from a body (like blood, plasma or skin). The current legislation is based on the need for further research to be conducted into the risks associated with transferring bacteria from a donor to a patient’s guts.

Fecal transplants have been found to be effective in treating gut infections such as Clostridium difficile bacterial infections when antibiotics have not worked. FMT is also thought to be able to treat symptoms of Crohn’s disease and irritable bowel syndrome, although the FDA only allows extreme cases of C diff to be treated by transplants at the moment.

So what?

The FDA legislation has faced opposition from both gastroenterologists and patients, on the basis that this change will restrict access to life-changing treatment. The American Gastroenterological Association has commented that the new rules could limit FMT only to larger hospitals. The ruling also places fecal transplants outside of medical insurance coverage, making it financially inaccessible for many. The American Gastroenterological Association have further expressed concerns that this may “inadvertently encourage patients to perform do-it-yourself FMT’ without medical supervision.

However, the risks and side-effects of introducing gut bacteria from one person to another appear to be complex. Concerns have emerged as a transplant from an overweight donor seems to have led to the recipient becoming obese.  Other side effects of FMT, such as the transfer of other diseases thought to originate in gut bacteria (such as immune disorders and cancer) are also yet to be fully understood.

Pharmaceutical companies have welcomed the FDA’s regulations on using donated stool samples. Companies such as Rebiotix and OpenBiome are in the process of developing pills using bacteria extracted from stools as a less invasive cure for gut infections. FDA regulations may be aiming to improve safety for FMT, however they are also strengthening the commercial pharmaceutical market for these pills (estimated to be worth $1.5 billion by 2024).

With increasing issues around microbial resistance, FMT represents an important area of research. However, doctors need to be able to guarantee the long-term recovery of patients, and the safety of fecal transplant operations.


A related signal was spotted by Esther Maughan McLachlan:

"The microbiome continues to be an area of high change potential - imagine the quality of life improvements and the financial savings if inflammatory bowel disorders could be treated from within?"

Scientists Are Now Trying Fecal Transplants on Kids

The human microbiome is a wild and wonderful thing. Billions of bacteria live in, on, and around us all, influencing our health in every way. Now, scientists are looking at whether fecal transplants-literally inserting another person's poop into a patient's gastrointestinal tract, via a colonoscopy or enema-could be a powerful way to manipulate the microbiome, and even to cure disease.



BuzzFeed (August 13, 2016) The FDA Wants To Make It Harder To Buy And Sell Poop, https://www.buzzfeed.com/nidhisubbaraman/fda-fecal-transplants?utm_term=.xny0O6Rb4#.dnpLN0xJn

New Scientist Special Report (February 26, 2014) Healing by faeces: Rise of the DIY gut-bug swap, https://www.newscientist.com/article/mg22129582-800-healing-by-faeces-rise-of-the-diy-gut-bug-swap/

MedicalNewsToday (February 18, 2015) Fecal matters: treating infection with stool transplants http://www.medicalnewstoday.com/articles/289613.php

Scientific American (October 7, 2013) Feces-Filled Pill Stops Gut Infection http://www.scientificamerican.com/article/feces-filled-pill-stops-gut-infection/

What might the implications of this be? What related signals of change have you seen?

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