A Clinical Study of Experimental RBX2660 to Restore Healthy Gut Bacteria in People With Recurrent Clostridium Difficile Infection
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"This study involves an investigational new drug called RBX2660 (microbiota suspension), that may prevent your recurrent CDI."
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Clostridium difficile Infection, Recurrent Clostridium difficile Infection, CDI, diarrhea
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
We invite you to take part in this research study if you have recurrent Clostridium difficile infection (CDI). This is an ongoing infection in your intestines. This infection causes severe diarrhea, called Clostridium difficile-associated diarrhea (CDAD). This research study is for an investigational new drug called RBX2660.
This study requires

If you take part in this research, you will be responsible to:

  • Be truthful with regard to your health and medications, including your medical history

  • Complete the study questionnaires and subject drug diary to the best of your ability

  • The expectation to return to the study site for every study visit, on time, and to take part in assessments made over the phone with the study team o If you are unable to come in for an appointment, call the study site to reschedule as soon as possible

  • Reporting all injuries, illnesses, doctor visits, hospitalizations, emergency room visits, symptoms or complaints to the study team as soon as possible even if you don’t think they relate to your CDI, enema product or the enema procedure

  • Calling the study team as soon as possible if your CDI returns to discuss further treatment

  • Follwing all the instructions given to you for this study including providing stool samples as requested

  • Agreeing to not take the following medications through the 8-week follow-up assessment unless specifically needed to treat a recurrence of CDI: o Oral Vancomycin o Metronidazole o Fidaxomicin o Rifaximin o Nitazoxinide o Intravenous Immunoglobulins (IVIG)

  • Agreeing to not take non-dietary probiotic supplements while participating in the study. You must not delay receiving your first enema, or your diarrhea may come back and you won’t receive the treatment or to continue in the study

  • Tell the study doctor or study team if you want to stop being in the study at any time

Who can participate

Inclusion criteria:

  1. ≥ 18 years old.
  2. Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
  3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
  4. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment. [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking this course of antibiotics]

Exclusion criteria:

  1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
  2. Previous fecal transplant
  3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  5. Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
  6. An absolute neutrophil count of <1000 cells/µL during screening.
  7. Pregnant, breastfeeding, or intends to become pregnant during study participation.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you or others from your taking part in this research. Possible benefits include the resolution of your recurrent CDI, but this benefit may or may not happen for you. Your willingness to take part, may, in the future, help doctors better understand and/or treat others who have your condition. You may contribute information that may benefit the development of a new drug to treat recurrent CDI.


RISKS:

There are risks, discomforts, and inconveniences to being in this study which your doctor will discuss with you. There are also unknown ways that this research may hurt you.
Compensation
If you agree to take part in this research study, we will compensate you for your time and effort.

You will get paid $50 for Baseline Visit, Weeks 1, 4, and 8, and $100 for Months 3 and 6 Visits, for a total of $400.

If you experience a recurrence and are seen for an unscheduled visit, you will receive an additional $50.

If you fail the treatment and require an additional, unblinded enema, you will receive $50 for the visit.

You may be asked for your social security number for payment purposes. It will not be used for any other purpose without your permission.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 9 months. At a minimum, you will need to come to the study center 5 times during the study and have 5 phone telephone contacts.
Recruitment period
From Dec. 15, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Clostridium Difficile Infection

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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