Aurora St. Luke’s Medical Center in Milwaukee has joined a study exploring a potential treatment for people with Clostridioides difficile, or C. diff, infection.
C. diff infection is a bacterial infection of the gut that researchers believe is caused by a disruption of the normal, healthy balance of microorganisms in the colon.
“Normally, our intestines are protected from C. diff infection by good bacteria, which also live in our gut and stop the bad organisms from reproducing,” said gastroenterologist Tarun Sharma, MD, Advocate Aurora Research Institute’s principal investigator for the study. “We become at risk for C. diff infection when we take antibiotics to treat other types of infection in our bodies. Although antibiotics kill the bad bacteria that make us sick, they may also kill the good bacteria that keep our intestines healthy.”
If a person already has or is exposed to C. diff while on antibiotics, they can develop a C. diff infection, which can cause life-threatening diarrhea, as well as fever, stomach pain, loss of appetite and nausea. C. diff infections affect roughly 500,000 people and kill between 15,000 and 20,000 people in the U.S. each year, according to the U.S. Centers for Disease Control and Prevention (CDC).
Because C. diff is a bacterium, it can also be treated with other types of antibiotics, but some people suffer from recurring C. diff infections even after seeing temporary symptom relief with antibiotics. About one in six people who get a C. diff infection will get it again in the subsequent two to eight weeks, according to the CDC.
“For decades, many doctors have treated people with C. diff infections by performing a fecal transplant,” Dr. Sharma said. “In this therapy, a healthy mix of microorganisms are introduced into the intestine of a patient with C. diff using a solution made from donated stool from a healthy person. However, no controlled clinical trials have ever studied fecal transplant as a treatment for recurrent C. diff infection.”
This clinical trial will evaluate the safety and tolerability of an investigational new drug, called RBX2660, in patients with recurrent C. diff infection. There is no placebo given in this study and the unique eligibility criteria allow for more patients to qualify for participation.
RBX2660 is a microbiota suspension, which is a type of biologic product made from living cells. Similar to fecal transplant treatments, RBX2660 is made from stool collected from healthy people and is given as an enema. However, RBX2660 is manufactured in a different way than fecal transplant products.
“Because C. diff is contagious, it can spread to anyone,” said Laura Wrona, MSN, director of specialty research for the Research Institute. “But people who are seeking antibiotic treatment for other illnesses, have weakened immune systems or are simply in a hospital for an extended time are particularly vulnerable. That’s why Advocate Aurora Health is particularly interested in clinical research that seeks treatments for this serious infection.”
The study, “Microbiota restoration therapy for recurrent Clostridium difficile infection (PUNCH CD3-OLS) (CD3-OLS),” will enroll up to 750 people at 80 hospitals and clinics in the U.S. and Canada. The study is sponsored by Rebiotix Inc., the manufacturer of RBX2660.
To learn more about Advocate Aurora’s research, visit aah.org/research.
