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NCT03110133 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
A Phase 2 study of Clostridium Difficile Infection Recurrence, sponsored by Finch Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
- 20
- Study locations
NCT03110133 is a Phase 2 study of Clostridium Difficile Infection Recurrence that has completed, run by Finch Research and Development. The registered enrollment target is 206 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT03110133, a Phase 2 study of Clostridium Difficile Infection Recurrence, has completed, sponsored by Finch Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Full Spectrum Microbiota
Study Locations (20)
California
- Los Angeles - Los Angeles
- Murrieta - Murrieta
- Oakland - Oakland
- San Diego - San Diego
- San Francisco - San Francisco
Florida
- Jacksonville - Jacksonville
- Naples - Naples
- Pinellas Park - Pinellas Park
- Tampa - Tampa
Illinois
- Burr Ridge - Burr Ridge
- Chicago - Chicago
- Evanston - Evanston
- Maywood - Maywood
Connecticut
- Bridgeport - Bridgeport
- Hamden - Hamden
Arizona
- Scottsdale - Scottsdale
Colorado
- Aurora - Aurora
District of Columbia
- Washington DC - Washington D.C.
Georgia
- Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2020-06-18 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03110133
The ClinicalTrials.gov registry entry for NCT03110133 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Finch Research and Development, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridium Difficile Infection Recurrence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03110133 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03110133 about?
NCT03110133 is a clinical study titled "Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff". 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. Subje...
What is the current status of trial NCT03110133?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2017-05-08. Estimated completion is 2020-06-18.
What conditions does trial NCT03110133 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection Recurrence.
What interventions are being tested in trial NCT03110133?
The interventions under investigation include: Placebo (DRUG), Full Spectrum Microbiota (DRUG).
Who is sponsoring clinical trial NCT03110133?
This trial is sponsored by Finch Research and Development, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03110133 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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