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| Name | Class |
|---|---|
| Rebiotix Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBX7455 Group A | Active Comparator | 4 days of 4 capsules twice daily RBX7455 for 10 subjects. |
|
| RBX7455 Group B | Active Comparator | 2 days of 4 capsules twice daily RBX7455 for 10 subjects. |
|
| RBX7455 Group C | Active Comparator | 2 days of 2 capsules twice daily RBX7455 for 10 subjects. |
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| RBX7455 Group D | Active Comparator | 2 days of 1 capsule twice daily RBX7455 for 10 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBX7455 | Biological | Microbiota capsule(s) given twice daily in the morning, and in the evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence of Clostridium Difficile Infection (CDI) | approximately 8 weeks | |
| Number of patients experiencing adverse events | approximately 6 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sahil Khanna | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32966574 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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