Trials / Completed
CompletedNCT02981316
Treatment of Recurrent Clostridium Difficile Infection With RBX7455
Treatment of Recurrent Clostridium Difficile Infection With RBX7455: A Dose-ranging, Prospective, Single Center, Open Label Phase I Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RBX7455 | Microbiota capsule(s) given twice daily in the morning, and in the evening. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2020-07-22
- Completion
- 2020-07-22
- First posted
- 2016-12-05
- Last updated
- 2020-12-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02981316. Inclusion in this directory is not an endorsement.