Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
Public ClinicalTrials.gov record NCT03931941. 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 Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.
Study identification
- NCT ID
- NCT03931941
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 793 participants
Conditions and interventions
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
- Jul 30, 2019 (Actual)
- Primary completion
- Jul 21, 2023 (Actual)
- Completion
- Jul 21, 2023 (Actual)
- Last update posted
- Aug 7, 2024
2019 – 2023
United States locations
- U.S. sites
- 46
- U.S. states
- 29
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix | Phoenix | Arizona | 85054 | — |
| North Little Rock | North Little Rock | Arkansas | 72117 | — |
| Oxnard | Oxnard | California | 93030 | — |
| Aurora | Aurora | Colorado | 80045 | — |
| Hamden | Hamden | Connecticut | 06518 | — |
| Gainesville | Gainesville | Florida | 32610 | — |
| Jacksonville | Jacksonville | Florida | 32224 | — |
| Naples | Naples | Florida | 34102 | — |
| Orlando | Orlando | Florida | 32806 | — |
| Port Orange | Port Orange | Florida | 32127 | — |
| Atlanta | Atlanta | Georgia | 30309 | — |
| Decatur | Decatur | Georgia | 30033 | — |
| Idaho Falls | Idaho Falls | Idaho | 83404 | — |
| Burr Ridge | Burr Ridge | Illinois | 60527 | — |
| Gurnee | Gurnee | Illinois | 60035 | — |
| Fort Wayne | Fort Wayne | Indiana | 46845 | — |
| Wichita | Wichita | Kansas | 67214 | — |
| New Orleans | New Orleans | Louisiana | 70121 | — |
| Shreveport | Shreveport | Louisiana | 71105 | — |
| Baltimore | Baltimore | Maryland | 21215 | — |
| Detroit | Detroit | Michigan | 48202 | — |
| Plymouth | Plymouth | Minnesota | 55446 | — |
| Rochester | Rochester | Minnesota | 55905 | — |
| St. Louis | St Louis | Missouri | 63110 | — |
| New York | New York | New York | 10016 | — |
| Rochester | Rochester | New York | 14618 | — |
| Durham | Durham | North Carolina | 27710 | — |
| Fargo | Fargo | North Dakota | 58122 | — |
| Cleveland | Cleveland | Ohio | 44195 | — |
| Oklahoma City | Oklahoma City | Oklahoma | 73102 | — |
| Philadelphia | Philadelphia | Pennsylvania | 19107 | — |
| Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Wyomissing | Wyomissing | Pennsylvania | 19610 | — |
| Charleston | Charleston | South Carolina | 29425 | — |
| Hixon | Hixon | Tennessee | 37434 | — |
| Nashville | Nashville | Tennessee | 37212 | — |
| Dallas | Dallas | Texas | 75246 | — |
| Houston | Houston | Texas | 77030 | — |
| West Jordan | West Jordan | Utah | 84088 | — |
| Annandale | Annandale | Virginia | 22003 | — |
| Springfield | Springfield | Virginia | 22150 | — |
| Seattle | Seattle | Washington | 98104 | — |
| Spokane | Spokane | Washington | 99202 | — |
| Madison | Madison | Wisconsin | 53704 | — |
| Marshfield | Marshfield | Wisconsin | 54449 | — |
| Milwaukee | Milwaukee | Wisconsin | 53215 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03931941, 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 Aug 7, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03931941 live on ClinicalTrials.gov.