Study investigates treatments for C diff infection in organ transplant recipients

Dr. Nasia Safdar in her laboratory

Nasia Safdar, MD, PhD (pictured above), professor, Infectious Disease and vice chair for research, has been awarded $5.1M over 5 years (U01 award) from the National Institutes of Health-National Institute of Allergy and Infectious Diseases for a proposal entitled, "Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients." 

Clostridium difficile infection, often referred to as C diff, is an infection that commonly spreads in hospitals and health care systems. Symptoms, which can include debilitating, severe diarrhea and life-threatening inflammation of the colon, occur when the bacterium C. difficile infects the gut. 

C. difficile bacteria are commonly found in the environment and some people naturally carry the microbes in their gut without having suffering from any ill effects, but C diff infection can be dangerous - especially for high-risk individuals such as people who are have weakened immune systems due to underlying medical issues or advanced age. In particular, C diff infection is a significant complication after solid organ transplantation, because immunosupressive drugs that organ donors need to take in order to prevent their bodies from rejecting the transplanted organ also leave them at higher risk of contracting this infection. 

Fecal microbiota transplantation (FMT) is a form of therapy that involves taking healthy stool from a donor and putting it into the intestine of a patient with C diff patient. Initial approaches with FMT have been promising, although the criteria for donors are so rigorous that only 2 percent of prospective donors are accepted. For example, FMT donors must not be taking any medications, have any chronic diseases, or have any infectious diseases. 

This NIH-funded study will compare the effectiveness of FMT with an antimicrobial drug (vancomycin) in 158 people who have both undergone solid organ transplantation, and who have a history of C diff infection.

Researchers will analyze blood and fecal samples, and assess how well each treatment improves their quality of life relative to C diff infection. Using the six fecal samples collected during the study, scientists will also assess the composition and function of gut microbial community in each volunteer.  

"By following patients for 6 months, we will determine whether FMT successfully and safely reduces recurrence of C diff infection (CDI) and improves other outcomes in solid organ transplant recipients with CDI," wrote Dr. Safdar. 

Additionally, Dr. Safdar was recently awarded more than $700,000 over four years from the Department of Veterans Affairs (MERIT Award) for a project entitled, "Mentored Enhanced Implementation and Evaluation of National VA Mandates To Prevent The Spread Of C difficile infection," which is focused on implementation science approaches to preventing C diff within Veterans Administration health care facilities, and more than $2.2M over 5 years from the National Institutes of Health (DP2 award) for a proposal entitled, "Modelling applications and systems engineering to reduce infections - the MASTERI study."