3 ms·
The FDA disagrees with you (about the role of the microbiome -- I doubt they have an official opinion on biotech funding). C. Diff. is probably the biggest indi
by armedgorillas 8y ago
The FDA disagrees with you (about the role of the microbiome -- I doubt they have an official opinion on biotech funding). C. Diff. is probably the biggest indication with multiple clinical trials going on to demonstrate the efficacy of full-spectrum fecal microbiota transplants as a therapeutic. Besides that, check out the work of the Allegretti or Borody labs for more human studies about the role of the microbiome in various metabolomic, developmental, and autoimmune diseases.
- refurb 8y agoFecal transplants are not new science and C. Difficle is just a bacterial infection. The relationship to microbiome science is minimal. As for the science around the microbiome role in metabolic, developmental and autoimmune disorder is observatory at best. I’ve yet to see a paper that took a human, changed their microbiome and observed X effect (beyond the obvious bacterial infection example).
- armedgorillas 8y agoI'm not quite following how the relationship between microbiome science and an infection of the microbiome is minimal. But more to your point, using the mg data from their "healthy" population along with the open-label data in the literature seems like a good way to construct RCTs, no? Data from open label studies isn't speculative... it's just not phase 3. In case you're curious, here are two papers on UC: https://www.ncbi.nlm.nih.gov/pubmed/28214091 https://www.ncbi.nlm.nih.gov/pubmed/28214091 and https://www.ncbi.nlm.nih.gov/pubmed/29052237 https://www.ncbi.nlm.nih.gov/pubmed/29052237