Patient FAQ

Patient FAQ

While Novel Biome does not sell directly to patients, we understand the importance of transparency and education. Explore our patient FAQ section to gain insights into FMT and Novel Biome’s commitment to high-quality and safe FMT. If you have inquiries that go beyond what's covered here, we strongly encourage you to consult with your medical doctor or healthcare provider for additional information and guidance.

Fecal microbiota transplantation (FMT) is the infusion of specially prepared stool material from a healthy donor(s) into the gut (intestinal tract) of a recipient to restore a healthy and stable microbial community and confer health benefits and/or treat a specific disease or symptom(s) 1–4. FMT helps re-educate the gut microbiome, restoring microbial diversity to donor-like proportions 5–7.

There are several ways FMT can be performed, including nasogastric and nasoduodenal tube, colonoscopy, retention enemas, oral capsules and our patent pending oral powder 1,7,8. The recent creation of FMT capsules that show comparable efficacy to lower GI methods, such as colonoscopy, combined with their convenience and safety, have made them an increasingly attractive option 8–20.

FMT has been widely and effectively used to treat recurrent Clostridium difficile infections (cDiff) in patients that are non-responsive to antibiotic therapy, with success rates of up to 90% 15,21–28.

Most reported adverse effects are mild transient symptoms, including mild fever, diarrhea, nausea, abdominal discomfort and bloating, which resolve quickly without intervention 4,21,29. FMT's most critical safety component involves appropriate donor screening and high-quality manufacturing.

At Novel Biome, we take safety, quality and stringent manufacturing standards seriously and keep these factors in mind through every step of the manufacturing process. We break our manufacturing into 3 steps:
  1. Donor screening and stool collection: The primary focus of Donor screening is to increase the safety of FMT by excluding known pathogens. Donor screening is designed to minimize the risk of transmitting potentially infectious diseases or contagious traits from donor to recipient. To determine a donor’s health, various types of screening are performed, including health and wellness questionnaires, blood testing, and stool testing. Generally, most potential donors are excluded during initial screening, and samples and donors are regularly tested to reduce risks.
  2. Manufacturing process: At Novel Biome, stool is processed in our state-of-the-art microbiome laboratory, which follows all regulatory guidelines and has stringent policies and Standard Operating Procedures. Our lab and processes are Good Manufacturing Practices (GMP) certified and, in addition, follow all Good Laboratory Practices (GLP).
  3. Storage and Delivery to Care Provider: All our finished products are stored in a temperature controlled environment. All our FMT products, capsules, dried powder, colonoscopy and enemas are freeze-dried, so they can be transported without being frozen and stored long-term at 4 degrees Celsius. Novel Biome is currently performing long-term stability tests in-house to ensure the best storage conditions are used to preserve the FMT products.

FMT has been widely and effectively used to treat recurrent Clostridium difficile infections (cDiff) in patients that are non-responsive to antibiotic therapy 15,21–25. FMT has demonstrated favourable clinical effectiveness in the treatment, decolonization and prevention of the recurrence of cDiff with high success rates and safety profiles 19,28,30–34. A recent analysis found a 92% clinical resolution rate compared to the first choice antibiotics against cDiff, vancomycin 26,28. In addition, another small-scale study showed that FMT leads to higher overall survival rates, shorter hospital stays, and lower rates of bloodstream infection in patients with recurrent cDiff than receiving antibiotics alone 31,35. Overall, FMT has been shown to be effective and has superior long-term efficacy compared to other medical treatments in cDiff 3,36,37.

Currently, FMT is most widely approved as a treatment for recurrent Clostridioides difficile infection (rcDiff) in patients that are non-responsive to antibiotic therapy 15,21–25. The promising outcomes of FMT to improve symptoms and alter the gut microbiota in patients with rcDiff have led to the expansion of research evaluating the efficacy of FMT for a wide variety of both gastrointestinal (GI) and non-GI disorders 4,21,29. Overall, there is a lack of large randomized controlled clinical trials. Still, the number of clinical trials is growing, with more than 300 publicly registered trials exploring FMT in May 2020, compared to less than 30 in 2013 3,21,31. A growing body of literature indicates that FMT may be a useful treatment option for 4,21,29:

References: 1. Choi, H. H. & Cho, Y.-S. 2016, 2. Gupta, S. et al. 2021, 3. Ser, H.-L. et al. 2021, 4. Xu, M.-Q. 2015, 5. Khanna, S. et al. 2017, 6. Song, Y. et al. 2013, 7. Wilson, B. C. et al. 2019, 8. Ramai, D. 2018, 9. Cold, F. et al. 2021, 10. Hirsch, B. E. et al. 2015, 11. Ramai, D. et al. 2021, 12. Krajicek, E. et al. 2019, 13. Baxter, M. & Colville, A. 2016, 14. Iqbal, U. et al. 2018, 15. Kao, D. et al. 2017, 16. Postigo, R. & Kim, J. H. 2012, 17. Reigadas, E. et al. 2020, 18. Wang, S. et al. 2016, 19. Youngster, I. et al. 2014, 20. Youngster, I. et al. 2016, 21. Allegretti, J. R. et al. 2019, 22. Cammarota, G. et al. 2015, 23. Lee, C. H. et al. 2016, 24. Lee, C. H. et al. 2019, 25. van Nood, E. et al. 2013, 26. Quraishi, M. N. et al. 2017, 27. Sommer, F. et al. 2017, 28. Basson, A. R. et al. 2020, 29. Brandt, L. J. & Aroniadis, O. C. 2013, 30. Austin, M. et al. 2014, 31. Gerardin, Y. et al. 2021, 32. Kelly, C. R. et al. 2016, 33. McCune, V. L. et al. 2014, 34. Rinott, E. et al. 2021, 35. Ianiro, G. et al. 2019, 36. Khan, M. Y. et al. 2018, 37. Moayyedi, P. et al. 2017, 38. Aldars-García, L. et al. 2021, 39. Anderson, J. L. et al. 2012, 40. Tan, P. et al. 2020, 41. Cruz-Aguliar, R. M. et al. 2019, 42. El‐Salhy, M. et al. 2022, 43. Allegretti, J. R. et al. 2021, 44. Kootte, R. S. et al. 2017, 45. Proença, I. M. et al. 2020, 46. Rinott, E. et al. 2021, 47. Zhang et al. 2019, 48. Kang, D.-W. et al. 2017, 49. Kang, D.-W. et al. 2019, 50. Li, N. et al. 2021, 51. Huang, H. et al. 2019, 52. Segal, A. et al. 2021, 53. Sun, M.-F. et al. 2018, 54. Makkawi, S. et al. 2018, 55. Borody, T.J. et al. 2011.