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COMPLETED Phase 2

Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff

NCT03110133 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 206 participants
Start Date 2017-05-08
Est. Completion 2020-06-18
Phase Phase 2

Sponsor

Finch Research and Development

2 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03110133 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03110133?

The interventions under investigation include: Placebo (DRUG), Full Spectrum Microbiota (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03110133?

This trial is sponsored by Finch Research and Development, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial