Treatment of Recurrent Clostridium Difficile Infection With RBX7455

NCT02981316 | Completed Phase 1 FDA Drug

• 1 other identifier: 15-008828
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (2)

• Time to recurrence of Clostridium Difficile Infection (CDI)

  approximately 8 weeks

• Number of patients experiencing adverse events

  approximately 6 months

Study Arms (4)

RBX7455 Group A

ACTIVE COMPARATOR

4 days of 4 capsules twice daily RBX7455 for 10 subjects.

Biological: RBX7455

RBX7455 Group B

ACTIVE COMPARATOR

2 days of 4 capsules twice daily RBX7455 for 10 subjects.

Biological: RBX7455

RBX7455 Group C

ACTIVE COMPARATOR

2 days of 2 capsules twice daily RBX7455 for 10 subjects.

Biological: RBX7455

RBX7455 Group D

ACTIVE COMPARATOR

2 days of 1 capsule twice daily RBX7455 for 10 subjects.

Biological: RBX7455

Interventions

RBX7455 BIOLOGICAL

Microbiota capsule(s) given twice daily in the morning, and in the evening.

RBX7455 Group A; RBX7455 Group B; RBX7455 Group C; RBX7455 Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Rebiotix Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Khanna S, Pardi DS, Jones C, Shannon WD, Gonzalez C, Blount K. RBX7455, a Non-frozen, Orally Administered Investigational Live Biotherapeutic, Is Safe, Effective, and Shifts Patients' Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections. Clin Infect Dis. 2021 Oct 5;73(7):e1613-e1620. doi: 10.1093/cid/ciaa1430.

  PMID: 32966574 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sahil Khanna

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.S.

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: November 1, 2016
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)