- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981316
Treatment of Recurrent Clostridium Difficile Infection With RBX7455
December 7, 2020 updated by: Sahil Khanna, Mayo Clinic
Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
The purpose of this study is to demonstrate the efficacy and safety of RBX7455 for the treatment of recurrent CDI in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- ≥ 18 years old.
- Medical record documentation of recurrent CDI, defined as at least one recurrence after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.
- A positive stool test for the presence of C. difficile within 30 days prior to enrollment and standard C. difficile treatment.
- Willing and able to swallow capsules.
- Agrees to abstain from non-dietary probiotics for the duration of the study.
- Agrees to abstain from vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide and IVIG for the duration of the study unless prescribed to treat recurrent CDI.
- Agrees to stop proton pump inhibitors or H2 blocker medications.
- Agrees to practice a form of effective contraception during study participation.
- Has a negative urine pregnancy test at the time of enrollment (females of child-bearing potential only).
- Willing and able to provide informed consent and HIPAA authorization.
- Willing and able to complete the required Subject Diary.
- Willing and able to meet all study requirements, including attending all assessment visits and phone calls.
Exclusion criteria:
- A known history of continued CDI diarrhea, despite being on a course of antibiotics prescribed for CDI treatment.
- Requires continuous antibiotic therapy for a condition other than CDI.
- Previous fecal transplant.
- Previous treatment with RBX2660.
- Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
- History of chronic diarrhea.
- History of celiac disease.
- Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
- Unable to stop proton pump inhibitors or H2 blocker medications.
- Colostomy.
- Intra-abdominal surgery within the last 60 days.
- Evidence of active, severe colitis.
- History of short gut syndrome.
- Requires the regular use of medications to manage bowel hypermotility.
- Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
- Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
- Life expectancy of < 6 months.
- Compromised immune system (e.g., HIV infection; AIDS-defining diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy; or current or recent (< 90 days) treatment with immunosuppressant medications.
- Taking systemic steroids (≥ 20 mg a day or prednisone-equivalent) or is expected to be on steroids after enrollment through 8 weeks after completing the assigned study treatment.
- An absolute neutrophil count of <1000 cells/µL.
- Known or suspected current (< 90 days) illicit drug use. Note: marijuana use is allowed.
- Pregnant, breastfeeding, or intends to become pregnant during study participation.
- Participating in a clinical trial of another investigational product (drug, device or other) and has not completed the required follow-up period.
- Subject, in the opinion of the investigator, for whatever reason, should be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RBX7455 Group A
4 days of 4 capsules twice daily RBX7455 for 10 subjects.
|
Microbiota capsule(s) given twice daily in the morning, and in the evening.
|
Active Comparator: RBX7455 Group B
2 days of 4 capsules twice daily RBX7455 for 10 subjects.
|
Microbiota capsule(s) given twice daily in the morning, and in the evening.
|
Active Comparator: RBX7455 Group C
2 days of 2 capsules twice daily RBX7455 for 10 subjects.
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Microbiota capsule(s) given twice daily in the morning, and in the evening.
|
Active Comparator: RBX7455 Group D
2 days of 1 capsule twice daily RBX7455 for 10 subjects.
|
Microbiota capsule(s) given twice daily in the morning, and in the evening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to recurrence of Clostridium Difficile Infection (CDI)
Time Frame: approximately 8 weeks
|
approximately 8 weeks
|
Number of patients experiencing adverse events
Time Frame: approximately 6 months
|
approximately 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sahil Khanna, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
July 22, 2020
Study Completion (Actual)
July 22, 2020
Study Registration Dates
First Submitted
December 1, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimate)
December 5, 2016
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 7, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-008828
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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