This study involves a microbiota suspension called RBX2660 that may prevent recurrent CDI. The microbiota suspension is a biologic product (a product made from living cells) made from stool collected from healthy people. It contains live intestinal microbes and may prevent recurrent CDI by restoring the normal balance of microorganisms in the intestines. The microbiota suspension was developed to help prevent new recurrences of CDI in people with recurrent CDI that is only controlled after taking antibiotics.
RBX2660 has already been tested in several clinical studies and is approved by the US Food and Drug Administration (FDA). RBX2660 is marketed in the United States as REBYOTA™ (fecal microbiota, live – jslm) for preventing recurrent CDI when introduced into the bowel through the rectum in patients with CDI. This way of administration is also called an enema and is designed to reach the lower bowel rather than the entire colon.
The purpose of this study is to learn about the safety of RBX2660 and how effective it is in preventing recurrence of CDI when it is delivered by colonoscopy in patients with recurrent CDI.
This study will take place at about 15 hospitals or clinics in the US and approximately 40 patients will be treated in this study.
If you are enrolled in the study, you will be followed by the study team for a maximum of 7 months. At a minimum, you will come to the study clinic 4 times during the study and will have 4 virtual appointments. The visits to the study clinic will require longer visits, approximately 1‑1.5 hours each. The virtual appointments are expected to take less than 30 minutes.
Items that may exclude you from this study will be reviewed with you. Some reasons may include:
Participation in this study may personally benefit you by preventing additional recurrences of your recurrent CDI, but this benefit cannot be guaranteed. Your willingness to take part in this study may, in the future, help doctors to better understand and/or treat other patients.
There is no charge for participation in this study and you may be compensated for time and travel. The study drug and all study-related costs for the required study visits (at the study site and virtual), tests, and procedures are covered by Ferring, the sponsor of the study.
If you are interested in participating, detailed information about the study will be given to you during a process called informed consent. You will have time to ask questions and talk with family and friends before enrolling in the study. Make sure all your questions are answered to your satisfaction before you agree to participate.