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Clostridium Difficile Infection RecurrencePhase 2PRISM3NCT03110133

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

A Phase 2 study testing Full Spectrum Microbiota in people with Clostridium Difficile Infection Recurrence, run by Finch Research and Development LLC. at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Full Spectrum Microbiota
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
58 sitesin 2 countries
Study dates
8 May 2017to 18 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to provide written informed consent
  • Men or women 18 years of age or older
  • Current diagnosis of a recurrence of non-severe, non-complicated CDI
  • Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode

Who cannot join

  • Pregnant, breast-feeding, or considering becoming pregnant during the study
  • Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
  • Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
  • Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
  • Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
  • Major intra-abdominal surgery within the past 60 days prior to Screening
Show all 10Show fewer
  • History of total colectomy/ileostomy or bariatric surgery
  • Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
  • Planned hospitalization or invasive surgery during the study
  • Severe acute illness unrelated to CDI

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United States54 sites

  • Annandale

    Annandale, Virginia, 22003

  • Atlanta

    Atlanta, Georgia, 30322

  • Aurora

    Aurora, Colorado, 80045

  • Boston

    Boston, Massachusetts, 02115

  • Bridgeport

    Bridgeport, Connecticut, 06610

  • Burr Ridge

    Burr Ridge, Illinois, 60527

  • Butte

    Butte, Montana, 59701

  • Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Charlottesville

    Charlottesville, Virginia, 22908

  • Chicago

    Chicago, Illinois, 60637

  • Cincinnati

    Cincinnati, Ohio, 45267

  • Detroit

    Detroit, Michigan, 48202

  • Evanston

    Evanston, Illinois, 60201

  • Grafton

    Grafton, Wisconsin, 53024

  • Hamden

    Hamden, Connecticut, 06518

  • Idaho Falls

    Idaho Falls, Idaho, 83404

  • Indianapolis

    Indianapolis, Indiana, 46202

  • Jacksonville

    Jacksonville, Florida, 32256

  • Kinston

    Kinston, North Carolina, 28501

  • Lancaster

    Lancaster, Pennsylvania, 17601

  • Los Angeles

    Los Angeles, California, 90095

  • Maywood

    Maywood, Illinois, 60153

  • Morristown

    Morristown, New Jersey, 07960

  • Murrieta

    Murrieta, California, 92563

  • Naples

    Naples, Florida, 34102

  • Nashville

    Nashville, Tennessee, 37212

  • New Orleans

    New Orleans, Louisiana, 70121

  • New York

    New York, New York, 10016

  • New York

    New York, New York, 10021

  • New York

    New York, New York, 10029

  • Oakland

    Oakland, California, 94705

  • Ogden

    Ogden, Utah, 84403

  • Pinehurst

    Pinehurst, North Carolina, 28374

  • Pinellas Park

    Pinellas Park, Florida, 33781

  • Poland

    Poland, Ohio, 44514

  • Portland

    Portland, Oregon, 97239

  • Providence

    Providence, Rhode Island, 02904

  • Rochester

    Rochester, Minnesota, 55905

  • Royal Oak

    Royal Oak, Michigan, 48073

  • St. Paul

    Saint Paul, Minnesota, 55130

  • Salt Lake City

    Salt Lake City, Utah, 84124

  • San Antonio

    San Antonio, Texas, 78229

  • San Diego

    San Diego, California, 92123

  • San Francisco

    San Francisco, California, 94115

  • Scottsdale

    Scottsdale, Arizona, 85054

  • Seattle

    Seattle, Washington, 98101

  • Shawnee

    Shawnee Mission, Kansas, 66217

  • Somers Point

    Somers Point, New Jersey, 08244

  • Tampa

    Tampa, Florida, 33614

  • Bronx

    The Bronx, New York, 10467

  • Washington DC

    Washington D.C., District of Columbia, 20422

  • West Des Moines

    West Des Moines, Iowa, 50266

  • Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Winston-Salem

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada4 sites

  • Calgary

    Calgary, Alberta, T2N 1N4

  • Halifax

    Halifax, Nova Scotia, B3H4C5

  • Toronto

    Toronto, Ontario, M5G 2C4

  • Toronto

    Toronto, Ontario

Other trials in Canada

About this study

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

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.

Read the detailed description

This is 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 (CDI).

Being tested
Full Spectrum Microbiota, Placebo
Keywords
Clostridium Difficile Infection, CP101, Crestovo, FMT, CDI, C. difficile, C. diff, Recurrent Clostridium Difficile Infection, Recurrent C. diff, Recurrent CDI, Finch, Fecal transplant, Fecal microbiota transplant, rCDI, Finch Therapeutics
Medical subject headings
Clostridium Infections, Diabetes Insipidus, Neurogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full Spectrum MicrobiotaDrug

    Also called CP101, FSM

    Orally administered donor derived microbiota

  • PlaceboDrug

    Placebo for CP101

Study groups in NCT03110133
Study groupRoleWhat they receive
CP101ExperimentalFull Spectrum Microbiota Capsule
Receives: Drug: Full Spectrum Microbiota
PlaceboPlacebo comparatorMatching Placebo Capsule
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication

    Defined in the protocol as sustained clinical cure

    Measured: Week 8

  2. Number of Participants With Occurrence of Treatment Emergent Adverse Events

    Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)

    Measured: Week 8

Secondary outcomes (3)

  1. Time to First Recurrent CDI Episode During the Study

    The number of days between IP administration and the first C. Difficile recurrence

    Measured: Week 8

  2. Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication

    Defined in the protocol as sustained clinical cure

    Measured: Week 24

  3. Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype

    NAP1 is the North American Pulse-field C. difficile subtype.

    Measured: Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start8 May 2017
  3. Primary completion28 Feb 2020
  4. Study completion18 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110133
Sponsor's protocol ID
CDI-001
Acronym
PRISM3
Status last verified
Sep 2022
First submitted
3 Apr 2017
Last updated
5 Oct 2022
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Allegretti JR, Kelly CR, Louie T, Fischer M, Hota S, Misra B, Van Hise NW, Yen E, Bullock JS, Silverman M, Davis I, McGill SK, Pardi DS, Orenstein R, Grinspan A, El-Nachef N, Feuerstadt P, Borody TJ, Khanna S, Budree S, Kassam Z. Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial. Gastroenterology. 2025 Feb;168(2):357-366.e3. doi: 10.1053/j.gastro.2024.09.030. Epub 2024 Oct 2.

    PubMed 39366468

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Full Spectrum Microbiota in people with Clostridium Difficile Infection Recurrence, run by Finch Research and Development LLC. at 58 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03110133, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.

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