Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Public ClinicalTrials.gov record NCT03110133. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile. Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.
Study identification
- NCT ID
- NCT03110133
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 206 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 8, 2017 (Actual)
- Primary completion
- Feb 28, 2020 (Actual)
- Completion
- Jun 18, 2020 (Actual)
- Last update posted
- Oct 5, 2022
2017 – 2020
United States locations
- U.S. sites
- 54
- U.S. states
- 30
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale | Scottsdale | Arizona | 85054 | — |
| Los Angeles | Los Angeles | California | 90095 | — |
| Murrieta | Murrieta | California | 92563 | — |
| Oakland | Oakland | California | 94705 | — |
| San Diego | San Diego | California | 92123 | — |
| San Francisco | San Francisco | California | 94115 | — |
| Aurora | Aurora | Colorado | 80045 | — |
| Bridgeport | Bridgeport | Connecticut | 06610 | — |
| Hamden | Hamden | Connecticut | 06518 | — |
| Washington DC | Washington D.C. | District of Columbia | 20422 | — |
| Jacksonville | Jacksonville | Florida | 32256 | — |
| Naples | Naples | Florida | 34102 | — |
| Pinellas Park | Pinellas Park | Florida | 33781 | — |
| Tampa | Tampa | Florida | 33614 | — |
| Atlanta | Atlanta | Georgia | 30322 | — |
| Idaho Falls | Idaho Falls | Idaho | 83404 | — |
| Burr Ridge | Burr Ridge | Illinois | 60527 | — |
| Chicago | Chicago | Illinois | 60637 | — |
| Evanston | Evanston | Illinois | 60201 | — |
| Maywood | Maywood | Illinois | 60153 | — |
| Indianapolis | Indianapolis | Indiana | 46202 | — |
| West Des Moines | West Des Moines | Iowa | 50266 | — |
| Shawnee | Shawnee Mission | Kansas | 66217 | — |
| New Orleans | New Orleans | Louisiana | 70121 | — |
| Boston | Boston | Massachusetts | 02115 | — |
| Detroit | Detroit | Michigan | 48202 | — |
| Royal Oak | Royal Oak | Michigan | 48073 | — |
| Rochester | Rochester | Minnesota | 55905 | — |
| St. Paul | Saint Paul | Minnesota | 55130 | — |
| Butte | Butte | Montana | 59701 | — |
| Morristown | Morristown | New Jersey | 07960 | — |
| Somers Point | Somers Point | New Jersey | 08244 | — |
| New York | New York | New York | 10016 | — |
| New York | New York | New York | 10021 | — |
| New York | New York | New York | 10029 | — |
| Bronx | The Bronx | New York | 10467 | — |
| Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Kinston | Kinston | North Carolina | 28501 | — |
| Pinehurst | Pinehurst | North Carolina | 28374 | — |
| Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Winston-Salem | Winston-Salem | North Carolina | 27157 | — |
| Cincinnati | Cincinnati | Ohio | 45267 | — |
| Poland | Poland | Ohio | 44514 | — |
| Portland | Portland | Oregon | 97239 | — |
| Lancaster | Lancaster | Pennsylvania | 17601 | — |
| Providence | Providence | Rhode Island | 02904 | — |
| Nashville | Nashville | Tennessee | 37212 | — |
| San Antonio | San Antonio | Texas | 78229 | — |
| Ogden | Ogden | Utah | 84403 | — |
| Salt Lake City | Salt Lake City | Utah | 84124 | — |
| Annandale | Annandale | Virginia | 22003 | — |
| Charlottesville | Charlottesville | Virginia | 22908 | — |
| Seattle | Seattle | Washington | 98101 | — |
| Grafton | Grafton | Wisconsin | 53024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03110133, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2022 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03110133 live on ClinicalTrials.gov.