Why The Research Is Interesting: Clostridium difficile infection (CDI) causes inflammation of the colon and severe diarrhea. The infection occurs when normal gut bacteria are disrupted. Fecal transplants to re-establish normal gut bacteria are the most effective treatment for preventing CDI in people who have already had the infection. Giving the treatment by a pill would save time and cost relative to giving the treatment by colonoscopy if the two treatments were no different.
Who and When: 116 patients with recurrent CDI enrolled from October 2014 to September 2016 and followed through 2016.
What (Study Measures):
Exposure: Patients were nearly evenly divided to receive a fecal transplant using a capsule or colonoscopy.
Outcome: Number of recurrent CDIs 12 weeks after fecal transplant.
How (Study Design): This was a noninferiority randomized clinical trial (RCT). Noninferiority RCTs are designed to assess whether one treatment (in this case capsule-based fecal transplant) was "no worse" than a comparison treatment (colonoscopy-based fecal transplant).
Authors: Dina Kao, M.D., F.R.C.P.C., of the University of Alberta, Edmonton, Canada, and coauthors.
Results: Recurrent CDI was prevented after a single treatment in 96 percent of patients in both groups after 12 weeks; more patients who received capsules rated their experience as "not at all unpleasant."
Study Limitations: Patients with severe and complicated CDI were excluded, so the findings may not apply to those cases.
Study Conclusions: Fecal transplant using oral capsules may be as effective as colonoscopy to prevent recurrent CDI.
###
Related material:
The following related elements also are available on the For The Media website:
- The editorial, "Capsules for Fecal Microbiota Transplantation in Recurrent Clostridium difficile Infection," by Preeti N. Malani, M.D., M.S.J., of the University of Michigan Health System, Ann Arbor, and Associate Editor, JAMA, and coauthors
Previous articles available from JAMA include:
Expanded Evidence for Frozen Fecal Microbiota Transplantation for Clostridium difficile Infection
Bezlotoxumab (Zinplava) for Prevention of Recurrent Clostridium Difficile Infection
A Patient Page, Fecal Microbiota Transplantation
Diagnosis and Treatment of Clostridium difficile in Adults
For more details and to read the full study, please visit the For The Media website.
(doi:10.1001/jama.2017.17077)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Journal
JAMA