Are you suffering from C. diff ?

Clinical Study Now Enrolling at
Medical Research Center of Connecticut, LLC
using Fecal Transplant Therapy.

Options now available for patients that do not qualify for other C. diff studies

Fecal Transplant Therapy Clinical Trial Now Enrolling
Fecal Transplant Therapy Clinical Trial Now Enrolling

Join the Battle to Defeat C. diff Infection

PUNCH CD3 and PUNCH CD3-OLS are clinical studies to evaluate the safety and efficacy of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (C. diff or CDI). With two study options available, 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 Candace L. Cotto, RN, CCRP at at Medical Research Center of Connecticut, LLC to learn more. With your help, we can put a stop to this deadly disease.

Call or E-mail to Find Out if You May Participate
Name: Candace L. Cotto, RN, CCRP
E-mail: ccotto@gastrocenter.org

To learn more about participating in the PUNCH CD3 or PUNCH CD3-OLS clinical study

The PUNCH CD3 and PUNCH CD3-OLS clinical studies are 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:

I am currently or have recently been treated for C. diff infection and am interested in participating in a recurrent C. diff study in my area.I am contacting you on behalf of a friend or family member that is currently or has recently been treated for C. diff infection.I am interested in learning more about C. diff infection.

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How to Participate

Patients that may qualify for the PUNCH CD3 or PUNCH CD3-OLS studies:

  • 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

The clinical study team will review the complete requirements and determine if you are eligible to participate in either clinical study. Personal information you share will be kept confidential.

If it is determined you may be a candidate for the PUNCH CD3 or CD3-OLS clinical study, you will:

  • Be asked to visit the clinical site if you are interested in participating
  • Receive detailed information regarding the clinical study, the risks and benefits of participating, and your responsibilities as a participant
  • Have time for your questions to be answered, and talk about the study with others (family and friends)
  • If you are confirmed to be a candidate and decide to participate, you may be compensated for completing required study visits and phone calls

To see if you may qualify for the PUNCH CD3 or PUNCH CD3-OLS clinical study

Fecal Transplant Therapy Clinical Trial Now Enrolling
Fecal Transplant Therapy Clinical Trial Now Enrolling

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 Studies?

Further information is available:


References

  1. Rupnik M, Wilcox MH, Gerding DN. Clostridium difficile Infection: new developments in epidemiology and pathogenesis.Nat Rev Microbiol. 2009;7(7):526-536.
  2. 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.
  3. 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.

Rebiotix

Rebiotix Inc.
2660 Patton Road
Roseville, MN 55113
www.rebiotix.com