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

NCT03110133 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CDI-001
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 58

Brief 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

Clostridium Difficile Infection Recurrence

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

Outcome Measures

Primary Outcomes (2)

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

  Defined in the protocol as sustained clinical cure

  Week 8

• 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)

  Week 8

Secondary Outcomes (3)

• Time to First Recurrent CDI Episode During the Study

  Week 8

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

  Week 24

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

  Up to Week 8

Study Arms (2)

CP101

EXPERIMENTAL

Full Spectrum Microbiota Capsule

Drug: Full Spectrum Microbiota

Placebo

PLACEBO COMPARATOR

Matching Placebo Capsule

Drug: Placebo

Interventions

Full Spectrum Microbiota DRUG

Orally administered donor derived microbiota

Also known as: CP101, FSM

CP101

Placebo DRUG

Placebo for CP101

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Finch Research and Development LLC.: lead

Study Sites (58)

Scottsdale

Scottsdale, Arizona, 85054, United States

Location

Los Angeles

Los Angeles, California, 90095, United States

Location

Murrieta

Murrieta, California, 92563, United States

Location

Oakland

Oakland, California, 94705, United States

Location

San Diego

San Diego, California, 92123, United States

Location

San Francisco

San Francisco, California, 94115, United States

Location

Aurora

Aurora, Colorado, 80045, United States

Location

Bridgeport

Bridgeport, Connecticut, 06610, United States

Location

Hamden

Hamden, Connecticut, 06518, United States

Location

Washington DC

Washington D.C., District of Columbia, 20422, United States

Location

Jacksonville

Jacksonville, Florida, 32256, United States

Location

Naples

Naples, Florida, 34102, United States

Location

Pinellas Park

Pinellas Park, Florida, 33781, United States

Location

Tampa

Tampa, Florida, 33614, United States

Location

Atlanta

Atlanta, Georgia, 30322, United States

Location

Idaho Falls

Idaho Falls, Idaho, 83404, United States

Location

Burr Ridge

Burr Ridge, Illinois, 60527, United States

Location

Chicago

Chicago, Illinois, 60637, United States

Location

Evanston

Evanston, Illinois, 60201, United States

Location

Maywood

Maywood, Illinois, 60153, United States

Location

Indianapolis

Indianapolis, Indiana, 46202, United States

Location

West Des Moines

West Des Moines, Iowa, 50266, United States

Location

Shawnee

Shawnee Mission, Kansas, 66217, United States

Location

New Orleans

New Orleans, Louisiana, 70121, United States

Location

Boston

Boston, Massachusetts, 02115, United States

Location

Detroit

Detroit, Michigan, 48202, United States

Location

Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Rochester

Rochester, Minnesota, 55905, United States

Location

St. Paul

Saint Paul, Minnesota, 55130, United States

Location

Butte

Butte, Montana, 59701, United States

Location

Morristown

Morristown, New Jersey, 07960, United States

Location

Somers Point

Somers Point, New Jersey, 08244, United States

Location

New York

New York, New York, 10016, United States

Location

New York

New York, New York, 10021, United States

Location

New York

New York, New York, 10029, United States

Location

Bronx

The Bronx, New York, 10467, United States

Location

Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Kinston

Kinston, North Carolina, 28501, United States

Location

Pinehurst

Pinehurst, North Carolina, 28374, United States

Location

Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Winston-Salem

Winston-Salem, North Carolina, 27157, United States

Location

Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Poland

Poland, Ohio, 44514, United States

Location

Portland

Portland, Oregon, 97239, United States

Location

Lancaster

Lancaster, Pennsylvania, 17601, United States

Location

Providence

Providence, Rhode Island, 02904, United States

Location

Nashville

Nashville, Tennessee, 37212, United States

Location

San Antonio

San Antonio, Texas, 78229, United States

Location

Ogden

Ogden, Utah, 84403, United States

Location

Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Annandale

Annandale, Virginia, 22003, United States

Location

Charlottesville

Charlottesville, Virginia, 22908, United States

Location

Seattle

Seattle, Washington, 98101, United States

Location

Grafton

Grafton, Wisconsin, 53024, United States

Location

Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Halifax

Halifax, Nova Scotia, B3H4C5, Canada

Location

Toronto

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 39366468 DERIVED

MeSH Terms

Conditions

Clostridium Infections; Diabetes Insipidus, Neurogenic

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Shrish Budree
• Organization: Finch Therapeutics

sbudree@finchtherapeutics.com

(857) 322-4646

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 12, 2017
• Study Start: May 8, 2017
• Primary Completion: February 28, 2020
• Study Completion: June 18, 2020
• Last Updated: October 5, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (54); CA (4)