Recurrent C. difficile Infection – Treatment; Rebiotix, Inc. Initiates Second Clinical Trial (PUNCH CD 2)

Rebiotixrecurrent-c-diff-clinical-study

Rebiotix Inc. is a results-oriented biotechnology company revolutionizing the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The company has completed the PUNCH CD study which assessed the safety and efficacy of RBX2660 (microbiota suspension) for the treatment of recurrent        C. diff. It is now working with the US Food and Drug Administration on the design of additional studies needed to make this therapy widely available to patients suffering from this debilitating condition.

Updated  24 November 2014

Rebiotix has initiated their second clinical trial (PUNCH CD 2) focusing on the treatment of recurrent C. difficile infection!

The PUNCH CD 2 study is a Phase 2B randomized controlled trial to assess the effectiveness and safety of RBX2660 (microbiota suspension) for the treatment of                                   recurrent  Clostridium difficile (C. diff.)  infection.

About the Study:   The PUNCH CD 2 study is the first multicenter prospective, multicenter, randomized, placebo-controlled, double-blind study of a microbiota restoration therapy. It has been designed to provide the highest quality of evidence to-date about this non-antibiotic approach to treating recurrent C. diff. infection.

Approximately 117 patients at over 20 sites in the US and Canada are expected to be enrolled in study.

Patients will be randomized into three different study groups: one group will receive two enemas containing RBX2660; another group will receive two enemas without the active drug; and the third group will receive one enema with RBX2660 and one without.  If a patient’s C. diff. infection reoccurs before 8 weeks after treatment, he or she may be eligible to crossover to receive active treatment with RBX2660.

All patients will be followed for 24 months after treatment.

Further Study Details

For more information on the study you may:

Find Out if You Could be Eligible

A physician participating in the PUNCH CD 2 study will determine if you are eligible to participate in the study. However, you can take a brief survey (less than 1 ½ minutes to complete) to learn if you meet the major study eligibility criteria.

How to Enroll as a Participant

If a study physician thinks you may be a good candidate, you will be given complete information about the study including the responsibilities for participation. You can find out if there is a study site near you by reviewing the clinical study site locations for PUNCH CD 2.

The PUNCH CD 2 Study is now open for enrollment. It is posted on ClinicalTrials.gov 

The number is NCT02299570.

To access the clinical trial information, please click on the link provided below.

http://www.rebiotix.com/index.php/rebiotix-clinical-program/punch-cd-2-clinical-trial

For more information about Rebiotix, Inc. please click on the link below:

www.rebiotix.com

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.