Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Recurrent Clostridium Difficile Infection With RBX7455

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02981316
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : December 8, 2020
Sponsor:
Collaborator:
Rebiotix Inc.
Information provided by (Responsible Party):
Sahil Khanna, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Biological: RBX7455 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
Study Start Date : November 2016
Actual Primary Completion Date : July 22, 2020
Actual Study Completion Date : July 22, 2020

Arm Intervention/treatment
Active Comparator: RBX7455 Group A
4 days of 4 capsules twice daily RBX7455 for 10 subjects.
Biological: RBX7455
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.
Biological: RBX7455
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.
Biological: RBX7455
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.
Biological: RBX7455
Microbiota capsule(s) given twice daily in the morning, and in the evening.




Primary Outcome Measures :
  1. Time to recurrence of Clostridium Difficile Infection (CDI) [ Time Frame: approximately 8 weeks ]
  2. Number of patients experiencing adverse events [ Time Frame: approximately 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. ≥ 18 years old.
  2. 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.
  3. A positive stool test for the presence of C. difficile within 30 days prior to enrollment and standard C. difficile treatment.
  4. Willing and able to swallow capsules.
  5. Agrees to abstain from non-dietary probiotics for the duration of the study.
  6. Agrees to abstain from vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide and IVIG for the duration of the study unless prescribed to treat recurrent CDI.
  7. Agrees to stop proton pump inhibitors or H2 blocker medications.
  8. Agrees to practice a form of effective contraception during study participation.
  9. Has a negative urine pregnancy test at the time of enrollment (females of child-bearing potential only).
  10. Willing and able to provide informed consent and HIPAA authorization.
  11. Willing and able to complete the required Subject Diary.
  12. Willing and able to meet all study requirements, including attending all assessment visits and phone calls.

Exclusion criteria:

  1. A known history of continued CDI diarrhea, despite being on a course of antibiotics prescribed for CDI treatment.
  2. Requires continuous antibiotic therapy for a condition other than CDI.
  3. Previous fecal transplant.
  4. Previous treatment with RBX2660.
  5. Diagnosis of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  6. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  7. History of chronic diarrhea.
  8. History of celiac disease.
  9. Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile.
  10. Unable to stop proton pump inhibitors or H2 blocker medications.
  11. Colostomy.
  12. Intra-abdominal surgery within the last 60 days.
  13. Evidence of active, severe colitis.
  14. History of short gut syndrome.
  15. Requires the regular use of medications to manage bowel hypermotility.
  16. Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).
  17. Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
  18. Life expectancy of < 6 months.
  19. 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.
  20. 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.
  21. An absolute neutrophil count of <1000 cells/µL.
  22. Known or suspected current (< 90 days) illicit drug use. Note: marijuana use is allowed.
  23. Pregnant, breastfeeding, or intends to become pregnant during study participation.
  24. Participating in a clinical trial of another investigational product (drug, device or other) and has not completed the required follow-up period.
  25. Subject, in the opinion of the investigator, for whatever reason, should be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981316


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Rebiotix Inc.
Investigators
Layout table for investigator information
Principal Investigator: Sahil Khanna Mayo Clinic
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sahil Khanna, M.B.B.S., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02981316    
Other Study ID Numbers: 15-008828
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases