C. difficile infection keeps us apart.

New research brings us closer together.

Now Enrolling in Your Area: The CDI-SCOPE study for adults with recurrent C. difficile infection (CDI).

If you are eligible and decide to participate:

There is no placebo
You will receive the study drug by colonoscopy
Study sponsor covers costs associated with participation

This clinical study tests an FDA-approved study drug when given by colonoscopy

CDI-SCOPE is a clinical study that investigates RBX2660 to find out if it can prevent recurrence of your CDI when administered through a colonoscopy.

The study drug, RBX2660, is approved by the US Food and Drug Administration (FDA), and marketed in the United States as REBYOTA™ (fecal microbiota, live – jslm)¹ for rectal administration only.

Study doctors want to find out if RBX2660 is also effective in preventing CDI recurrence when given by colonoscopy.

There is no placebo and you may be compensated for your time and travel

Study patients receive expert medical care and specialized attention from the study team. There is no placebo drug given and you do not have to pay for the study drug, supplies, procedures, or tests that are part of the study.

Your participation will help us understand more about RBX2660 in people with recurrent CDI.

If you or someone you know has a C. difficile infection, contact the clinical study team to learn more.

To learn more about participating in the CDI-SCOPE clinical study

CLICK HERE TO CONTACT US

How to Participate in This Study

To be eligible, you must be:

At least 18 years old
Diagnosed with recurrent CDI
Able to give informed consent

This is not a complete list of study requirements. The clinical study team will review the complete requirements with you and determine if you are eligible to participate in the clinical study.

If it is determined you may be a candidate for the CDI-SCOPE 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 (your doctor, 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 CDI-SCOPE clinical study

CLICK HERE TO CONTACT US

Frequently Asked Questions

What is a clinical study?

In a clinical study like this one, participants receive a study drug to find out if it is effective, and whether or not it has side effects.

What is a study drug?

A study drug is a substance that is being tested in clinical studies. The study is reviewed by an ethics committee that approves testing the study drug in people.

Why is this study important?

Individuals with recurrent CDI can suffer from repeated episodes of severe diarrhea and other difficult symptoms that not only interrupt day-to-day activities but can create a serious burden on life. Many people with this condition are successfully treated with antibiotics, but these can cause even more disruption to the gut. Unfortunately, this disruption can sometimes lead to additional CDI episodes when the antibiotics are stopped.

This study is evaluating a United States Food and Drug Administration (FDA) approved study drug called RBX2660 (REBYOTA) to find out how it works when administered through a colonoscopy. Pharmaceutical companies use clinical studies like this one to learn more about study drugs before and after they are made available to the public. Study participants can help us in this important research.

Why should I take part in this study?

Participation in a clinical trial is voluntary. Clinical studies are important for medical advances. Current treatments for diseases have only become available because individuals agreed to participate in clinical studies.

Thank you for considering participation in this study.

CLICK HERE TO CONTACT US

1. US Food and Drug Administration. FDA Approves First Fecal Microbiota Product. https://www.fda.gov/news-events/press-announcements/fda-approves-first-fecal-microbiota-product. Accessed December 1, 2022.

The CDI-SCOPE 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:

What is the gut microbiome?

The microbiome is the community of tiny living cells living on or inside the human body.¹ It is made of:

Bacteria
Viruses
Fungi

¹https://www.hmpdacc.org/hmp/overview

What is Clostridioides difficile?

CDI is a bacterial infection of the gut (intestines). In the US, Clostridioides difficile accounts for nearly half a million infections and approximately 29,000 deaths each year. It is believed that CDI is caused by a disruption of the normal, healthy balance of microorganisms (tiny living cells such as bacteria) in the gut after taking antibiotics. Many people with CDI are cured with a course of antibiotics but this is not the case for everyone. Some people have repeated episodes of severe diarrhea that resolve while the person is taking antibiotics but the diarrhea typically returns when the antibiotics are stopped. This type of CDI is called “recurrent CDI”.

How is recurrent CDI treated?

For many years, doctors have treated people with recurrent CDI with a solution made of stool (poop or feces) from healthy people. The goal of this treatment is to prevent recurrence of diarrhea by introducing a healthy mix of microorganisms to the intestines. This therapy is called “fecal transplant”. Doctors have found that a fecal transplant can be an effective way to prevent recurrence of CDI. In many instances, doctors use a procedure called colonoscopy to deliver the fecal transplant into the large bowel (last part of the intestines, also called colon).

What is RBX2660?

This study involves a microbiota suspension (called RBX2660), that may prevent CDI recurrence. The microbiota suspension is a biologic product (a product made from living cells) made from stool collected from healthy people. The microbiota suspension contains live intestinal microbes and may prevent recurrent CDI by restoring the normal balance of microorganisms in the intestines. The microbiota suspension is developed to help prevent new recurrences of CDI in people with recurrent CDI.

RBX2660 has already been shown to be effective and safe in several studies when introduced into the bowel through the anus 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, therefore, 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 approximately 10 to 20 hospitals or clinics in the US. Approximately 40 patients will be treated in this study.

If you decide to participate in this study, you might have to stop taking some of your regular medication(s) or supplement(s). The study doctor will discuss this with you.

Who Is Paying for This Clinical Study?

Ferring Pharmaceuticals A/S (Ferring) is the sponsor of the study, and pays the study clinics and study doctors to conduct this study. In addition to the study doctor, there are other study staff that will be involved in the study and data collection (we call these people the study team).

How Long Will I Participate in the Clinical Study?

If you are 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, for example by telephone. You might need to come to the study clinic for the appointments planned to be virtual if your study doctor deems it necessary. The visits to the study clinic (screening visit, baseline visit, 8-week visit, and 6-month visit, also called end-of-trial visit) will require longer visits, approximately 1‑1.5 hours each. The virtual appointments are expected to take less than 30 minutes. If you need to come to the study clinic for the virtual appointments, the amount of time required will be about 30-45 minutes. Extra visits may be required if your CDI returns while you are participating in the study.

Are There Reasons Why I Should Not Take Part in the Study?

If you are pregnant, breastfeeding, or plan to become pregnant during the course of the study you should not participate in this study, because it is currently not known if receiving RBX2660 is associated with any risks to the embryo, fetus, or nursing child. If you participate in this study, you must be willing to use appropriate birth control measures (contraception), to prevent pregnancy (in you or your partner) during the study; the study doctor will talk to you about what may be the most appropriate for your circumstances. If you are a woman who could become pregnant, you will take a pregnancy test when you enter the study and during the study before receiving treatment to make sure that you are not pregnant. You will also take a pregnancy test when you exit the study. If you become pregnant during the study, you should tell your study doctor or a member of the study team as soon as possible and you will not receive any further study medication. Your pregnancy will be followed until delivery. If you are male and fathered a child during your participation in the study, your study doctor will also ask to receive information about the outcome of your partner’s pregnancy.

Additional items that may exclude you from this study will be reviewed with you by your study doctor and/or their staff prior to your participation in this study. Some reasons may include:

You have certain other bowel disorders or had recent gastrointestinal surgery.
You take high doses of immunosuppressive medications or are receiving chemotherapy.
You abuse alcohol or drugs.

WHAT WILL HAPPEN DURING THIS CLINICAL STUDY?

There are screening tests to see if you qualify to continue in the study. Not everyone who is screened will continue in the study and receive treatment. All testing is described below.

If your study doctor thinks you might be a good candidate for this study, a member of the study team will talk to you about your recurrent CDI condition and the benefits, risks, and responsibilities you will have as a study participant. If you agree to be part of the study, you will sign this Informed Consent Form, and undergo screening tests and an evaluation by the study team to confirm you meet all the requirements of this study.

In this study you will receive treatment with the active drug RBX2660. RBX2660 will be administered to your colon by colonoscopy. Before the colonoscopy you will need to clean your bowel with a bowel cleansing product used to remove stool so the doctor performing the colonoscopy can see the colon clearly. Your study doctor will inform you about the procedure and any appropriate measures you need to take before and after the procedure.

If your diarrhea returns within 8 weeks after receiving the study drug and you have a positive stool test for Clostridioides difficile toxin, your study doctor will discuss alternative treatment options with you. You will still remain in the study through the 6-month study visit. If you experience symptoms indicative of CDI after the week 8 visit, your study doctor will discuss diagnostic and alternative treatment options with you. You will still remain in the study through the 6-month study visit.

Will Participating in This Clinical Study Help Me?

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. Your participation in this clinical study may contribute information that may benefit the development of a new drug to treat recurrent CDI to benefit patients like you in the future.

What Is My Alternative to Participating in This Clinical Study?

You do not have to participate in this study to get help for your recurrent CDI. Before you decide if you want to participate in the study, you should discuss other treatment options for your recurrent CDI with the study doctor, including the important risks and benefits related to the treatment options. In addition, you may discuss your options with your regular health care provider as well.

Will I Be Compensated if I Participate in This Clinical Study?

You will not be paid to participate in this study. However, you will receive other benefits as described here.

There will be no charge to you for your participation in this study. All the study related research costs for the required study visits (at-site and virtual), colonoscopy, and study drug(s) will be provided at no charge to you by Ferring, the sponsor of the study. The Institutional Review Boards (IRBs) have been informed of the financial contract between Ferring and the clinic.

While you are in the study, you may still need to receive regular medical care from your primary care doctor. Ferring will not pay for medications or procedures that are not needed for this study.

If you participate in the optional patient-experience interview you will receive a check of US $125.