C. diff – Get Involved305admin2020-09-21T13:52:21+00:00
Join the Battle to Defeat C. diff Infection
If you have been diagnosed C. diff, you are not alone. A research study at the Louisiana Research Center aims to stop C. diff from returning.
PUNCH CD3-OLS is a clinical study to evaluate the safety and tolerability of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (C. diff or CDI). With this study option, many more people that suffer from recurrent C.diff may now qualify for study participation.
Study patients receive expert medical care and specialized attention from the study team. The cost of the study drug, study-related tests, as well as study follow-up calls and visits will be covered by the study sponsor, Rebiotix.
How to Participate
Patients that may qualify for the PUNCH CD3-OLS study:
18 years and older
Have experienced more than one C diff infection
Currently taking or just prescribed antibiotics to control C diff diarrhea
Willing and able to meet all study requirements
What is RBX2660 and how does it prevent C. diff infection?
RBX2660 (microbiota suspension) is an investigational new drug that may prevent recurrent C. diff infection from returning. It is a biologic drug product prepared from live intestinal microbes, which are tiny living cells that can’t be seen without a microscope. The study drug is delivered in a single simple enema, unlike Fecal Microbiota Transplant (FMT) by colonoscopy or taking many pills.
Everyone has “good” and “bad” microbes that live in their intestines. In healthy people, the good microbes keep the bad microbes in balance. There is scientific evidence that people who experience repeated episodes of C. diff may have an imbalance in their intestines that allows the “bad” microbes to grow more easily and overtake the good microbes, which causes severe diarrhea and other symptoms, and can be life-threatening.1
Some research studies have shown that putting a mix of good microbes into the intestines of someone infected with C. diff may relieve or stop recurrent C. diff.2,3 The purpose of this study is to learn about the safety of RBX2660, and determine whether it is effective at preventing recurrent C. diff infections.
Rupnik M, Wilcox MH, Gerding DN. Clostridium difficileInfection: new developments in epidemiology and pathogenesis. Nat Rev Microbiol. 2009; 7(7):526-536.
van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal Infusion of donor feces for Recurrent Clostridium difficle. N Eng J Med 2013; 386(5):407-415.
Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for Recurrent Clostridium difficile Clin Infect Dis. 2011 Nov; 53(10):994-1002.