Norwegian Pilot Study Published In The New England Journal of Medicine
A Norwegian pilot study published in the June 2, 2018 edition of the New England Journal of Medicine shows that a supply of intestinal bacteria can be better than antibiotics for all patients with Clostridium difficile Infection, including those who have it for the first time. The study, Fecal Microbiota Transplantation for Primary Clostridial Difficile Infection examined whether the intestinal bacterial infections of a healthy person (fecal microbial transplantation) can restore a healthy and resilient intestinal flora so that the patient with C Diff infection can get rid of the infection without resorting to antibiotics.
There is great international interest in these findings. The New York Times June 2, 2018 edition, featured the study in an article titled Antibiotics Weren’t Used to Cure These Patients. Fecal Bacteria Were. The study was also presented June 2 at the world’s largest digestive disease conference, Digestive Disease Week 2018.
Dr. Michael Bretthauer, M.D., Ph.D. University of Oslo, and Frontier Science President, along with colleagues Frederik Emil Juul and Kjetil Kjeldstad Garborg from Oslo University Hospital, Oslo, Norway, and others, undertook a proof-of-concept trial (ClinicalTrials.gov number, NCT02301000) to evaluate the use of fecal microbiota transplantation as treatment for primary C. difficile infection. The results suggest that fecal microbiota transplantation may be an effective alternative to antibiotic therapy in primary C. difficile infection. A phase 3 trial to assess fecal microbiota transplantation as primary treatment for C. difficile infection is under way.
“If the results of the pilot study are confirmed in the major study, it may change the treatment of C Diff infections worldwide. It will be both good for patients and useful for society,” said Michael Bretthauer, the article’s last author and professor at the University of Oslo.
About the Study
Writers: Frederik E. Juul, MD, Hilde Skudal, MD, Mari N. Øines, MD, Håvard Wiig, MD, Øystein Rose, MD, Birgitte Seip, MD, Ph.D., J. Thomas Lamont, MD, Tore Midth, MD, Ph.D., Jørgen Valeur, MD, Ph.D., Mette Kalager, MD, Ph.D., Øyvind Holme, MD, Ph.D., Lise Helsingen, MD, Magnus Løberg, MD, Ph.D. . and Hans-Olov Adami, MD, Ph.D. Kjetil Garborg, MD, Ph.D. and Michael Bretthauer, MD Ph.D.
Cooperative institutions: Oslo University Hospital, University of Oslo, Telemark Skien Hospital, Sørlandet Hospital Kristiansand, Vestre Viken Bærum Hospital, Vestfold Hospital, Karolinska Institutet Stockholm and Lovisenberg Diakonale Hospital Oslo.