Are you suffering from C. diff ?
Clinical Study Now Enrolling
Sierra Clinical Research
using Fecal Transplant Therapy.
Options now available for patients that do not qualify for other C. diff studies
Join the Battle to Defeat C. diff Infection
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.
If you or someone you know has a C. diff infection, contact Maya Pudi, MBS, CCRC at Sierra Clinical Research to learn more. With your help, we can put a stop to this deadly disease.
To learn more about participating in the PUNCH CD3-OLS clinical study
The PUNCH CD3-OLS clinical study is open for adults with recurrent C. diff infection that is only controlled by taking antibiotics. To speak with the clinical research coordinator at a study site in your area, please provide the following information:
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 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 infection.
Want More Information About the Study?
Further information is available:
- Rupnik M, Wilcox MH, Gerding DN. Clostridium difficile Infection: 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 infection. Clin Infect Dis. 2011 Nov;53(10):994-1002.
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