Are you suffering from C. diff ?

Clinical Study Now Enrolling at
University of Kentucky
using Fecal Transplant Therapy.

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

The PUNCH CD3 clinical study is open for adults with recurrent C. difficile 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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Fecal Transplant Therapy Clinical Trial Now Enrolling

Purpose of This C. diff Infection Clinical Study

PUNCH CD3 is a clinical study to evaluate the safety and efficacy of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI). This is the fourth investigational new drug clinical study evaluating RBX2660 for recurrent CDI. It is common for new drugs to undergo multiple studies before being approved by the Food and Drug Administration (FDA).

If you or someone you know has C. diff infection, contact Malissia VanHook at University of Kentucky to learn more.

Call or E-mail to Find Out if You May Participate

Name: Malissia VanHook
E-mail: macald0@uky.edu

To learn more about participating in the PUNCH CD3 clinical study

How to Participate

The clinical study coordinator will determine if you are eligible to participate in this clinical research study. Any personal information you share will be kept confidential.

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

  • Be given complete information about the study
  • Have time for your questions to be answered, and talk about the study with others (family and friends)
  • 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
  • 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 learn more about participating in the PUNCH CD3 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.

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:

punch cd 3 patient brochure

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