Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP101 | Experimental | Full Spectrum Microbiota Capsule |
|
| Placebo | Placebo Comparator | Matching Placebo Capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Spectrum Microbiota | Drug | Orally administered donor derived microbiota |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Recurrent CDI Episode During the Study | The number of days between IP administration and the first C. Difficile recurrence | Week 8 |
| Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Scottsdale | Arizona | 85054 | United States | ||
| Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39366468 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CP101 | Full Spectrum Microbiota Capsule Full Spectrum Microbiota: Orally administered donor derived microbiota |
| FG001 | Placebo | Matching Placebo Capsule Placebo: Placebo for CP101 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Week 8 |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2019 | Apr 25, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo for CP101 |
|
Defined in the protocol as sustained clinical cure
| Week 24 |
| Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype | NAP1 is the North American Pulse-field C. difficile subtype. | Up to Week 8 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Murrieta | Murrieta | California | 92563 | United States |
| Oakland | Oakland | California | 94705 | United States |
| San Diego | San Diego | California | 92123 | United States |
| San Francisco | San Francisco | California | 94115 | United States |
| Aurora | Aurora | Colorado | 80045 | United States |
| Bridgeport | Bridgeport | Connecticut | 06610 | United States |
| Hamden | Hamden | Connecticut | 06518 | United States |
| Washington DC | Washington D.C. | District of Columbia | 20422 | United States |
| Jacksonville | Jacksonville | Florida | 32256 | United States |
| Naples | Naples | Florida | 34102 | United States |
| Pinellas Park | Pinellas Park | Florida | 33781 | United States |
| Tampa | Tampa | Florida | 33614 | United States |
| Atlanta | Atlanta | Georgia | 30322 | United States |
| Idaho Falls | Idaho Falls | Idaho | 83404 | United States |
| Burr Ridge | Burr Ridge | Illinois | 60527 | United States |
| Chicago | Chicago | Illinois | 60637 | United States |
| Evanston | Evanston | Illinois | 60201 | United States |
| Maywood | Maywood | Illinois | 60153 | United States |
| Indianapolis | Indianapolis | Indiana | 46202 | United States |
| West Des Moines | West Des Moines | Iowa | 50266 | United States |
| Shawnee | Shawnee Mission | Kansas | 66217 | United States |
| New Orleans | New Orleans | Louisiana | 70121 | United States |
| Boston | Boston | Massachusetts | 02115 | United States |
| Detroit | Detroit | Michigan | 48202 | United States |
| Royal Oak | Royal Oak | Michigan | 48073 | United States |
| Rochester | Rochester | Minnesota | 55905 | United States |
| St. Paul | Saint Paul | Minnesota | 55130 | United States |
| Butte | Butte | Montana | 59701 | United States |
| Morristown | Morristown | New Jersey | 07960 | United States |
| Somers Point | Somers Point | New Jersey | 08244 | United States |
| New York | New York | New York | 10016 | United States |
| New York | New York | New York | 10021 | United States |
| New York | New York | New York | 10029 | United States |
| Bronx | The Bronx | New York | 10467 | United States |
| Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Kinston | Kinston | North Carolina | 28501 | United States |
| Pinehurst | Pinehurst | North Carolina | 28374 | United States |
| Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Winston-Salem | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Poland | Poland | Ohio | 44514 | United States |
| Portland | Portland | Oregon | 97239 | United States |
| Lancaster | Lancaster | Pennsylvania | 17601 | United States |
| Providence | Providence | Rhode Island | 02904 | United States |
| Nashville | Nashville | Tennessee | 37212 | United States |
| San Antonio | San Antonio | Texas | 78229 | United States |
| Ogden | Ogden | Utah | 84403 | United States |
| Salt Lake City | Salt Lake City | Utah | 84124 | United States |
| Annandale | Annandale | Virginia | 22003 | United States |
| Charlottesville | Charlottesville | Virginia | 22908 | United States |
| Seattle | Seattle | Washington | 98101 | United States |
| Grafton | Grafton | Wisconsin | 53024 | United States |
| Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| Halifax | Halifax | Nova Scotia | B3H4C5 | Canada |
| Toronto | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto | Toronto | Ontario | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
| Week 24 |
|
Modified Intent to Treat (mITT) population used
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CP101 | Full Spectrum Microbiota Capsule Full Spectrum Microbiota: Orally administered donor derived microbiota |
| BG001 | Placebo | Matching Placebo Capsule Placebo: Placebo for CP101 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Total Number of C. difficile Infection (CDI) Episodes in Previous 12 Months | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication | Defined in the protocol as sustained clinical cure | mITT population | Posted | Count of Participants | Participants | Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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) | Safety population | Posted | Count of Participants | Participants | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Recurrent CDI Episode During the Study | The number of days between IP administration and the first C. Difficile recurrence | mITT population | Posted | Mean | Standard Deviation | Days | Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication | Defined in the protocol as sustained clinical cure | Posted | Count of Participants | Participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype | NAP1 is the North American Pulse-field C. difficile subtype. | Analysis population only included participants with a CDI recurrence up to week 8. Two of the recurrences in the primary efficacy analyses were imputed, therefore only 24 samples were available for this analysis. | Posted | Count of Participants | Participants | Up to Week 8 |
|
|
24 weeks
Based on Safety population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CP101 | Full Spectrum Microbiota Capsule Full Spectrum Microbiota: Orally administered donor derived microbiota | 1 | 104 | 16 | 104 | 97 | 104 |
| EG001 | Placebo | Matching Placebo Capsule Placebo: Placebo for CP101 | 2 | 99 | 13 | 99 | 92 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Cholecystitis infective | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Metapneumovirus infection | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Pleurisy viral | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Left ventricular failure | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Volvulus of small bowel | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Gallbladder cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Traumatic hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Iron deficiency anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal hematoma | Renal and urinary disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Device occlusion | Product Issues | Systematic Assessment |
| ||
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Defaecation urgency | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal tenderness | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anal incontinence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pus in stool | Investigations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
The disclosure restrictions on the PI are: (i) the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to eighteen months from the lock-down of all study data and (ii) the sponsor can require the removal of its confidential information from results communications and may delay release for a period of up to 60 days for the purpose of filing patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shrish Budree | Finch Therapeutics | (857) 322-4646 | 646 | sbudree@finchtherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2021 | Apr 25, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D020790 | Diabetes Insipidus, Neurogenic |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 |
|
| 3 |
|
| >3 |
|
|
|
|
|
|