← Back to Search

Microbiome Modulator

CP101 for Clostridioides difficile Infection (PRISM4 Trial)

Phase 3

Waitlist Available

Research Sponsored by Finch Research and Development LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

PRISM4 Trial Summary

This trial is testing a new drug, CP101, to see if it can prevent recurrent Clostridioides difficile infections (CDI). The trial will have two parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm.

Eligible Conditions

Clostridioides difficile (C. diff) Infection

PRISM4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sustained Clinical Cure Through Week 8

Secondary outcome measures

CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture

Sustained Clinical Cure Through Week 24

Other outcome measures

Improvement of Intestinal Microbiome Diversity at Week 1 as Determined by 16S Ribosomal Ribonucleic Acid (rRNA) Gene Amplicon Sequencing

PRISM4 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CP101Active Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Finch Research and Development LLC.Lead Sponsor

4 Previous Clinical Trials

338 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has CP101 been cleared by the FDA for use?

"CP101 has received a score of 3 for safety. This is because CP101 is in Phase 3 clinical trials, meaning that there is both efficacy and safety data supporting its use."

Answered by AI

Can new participants join the research project at this time?

"As stated on clinicaltrials.gov, this research is actively recruiting potential participants. The listing was first posted on November 15th, 2021 and was updated on October 31st, 2022."

Answered by AI

Are there many different hospitals running this study in different states?

"Patients can receive this treatment at Main Street Physicians Care in Loris, California, East Bay Endosurgery Center in Oakland, Alabama, Metro Infectious disease Consultants in Huntsville, Tennessee, and 71 other clinics."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)

2021. "A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153499.