A Phase 2 interventional study of CP101 in Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection and C. Diff, sponsored by Finch Research and Development LLC.. Completed at 57 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by Finch Research and Development LLC. · Phase 2, Interventional, and Treatment
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Among 121 studies in Clostridium Infections with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Clostridium Infections · United States.
Among the 121 studies in Clostridium Infections with a site in United States, this one is the 33rd largest by enrollment of the 102 interventional ones that give a count, is one of 9 that started in 2018, is one of 32 in phase 2, and was the 66th registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →16 of the 121 studies in Clostridium Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Healthy volunteers
Acurx Pharmaceuticals Inc. · Sites in United States
Ages 18–90
Medical College of Wisconsin · Sites in United States
Ages 18+
University of Michigan · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, Australia, Canada and 11 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 40 · Phase 3 21 · Phase 4 14
First in 1998; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 132 is above the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Median enrollment 57 across the 102 interventional studies, 132 across the 19 observational. Of the 91 that completed or were terminated, 52 (57%) have results posted.
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48 of 121 have an industry lead sponsor. The 10 most frequent:
Finch Research and Development LLC. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Finch Research and Development LLC. has 3 studies filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Clostridium Infections with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221370Phase 3Riverside University Health System Medical CenterEnteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients | 2026-12-31 |
| NCT06237452Phase 3Vedanta Biosciences, Inc.VE303 for Prevention of Recurrent Clostridioides Difficile Infection | 2027-06 |
| NCT04305769University of VirginiaAlanyl-glutamine Supplementation for C. Difficile Treatment (ACT) | 2026-12-31 |
| NCT07250724Bactolife A/SC. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI. | 2027-01-15 |
| NCT07285213AstraZenecaPrevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | 2027-04-20 |
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Among the 121 studies in Clostridium Infections with a site in United States, from their registry updates:
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This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101.
Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The active ingredient of CP101, Full-Spectrum Microbiota™, is derived from the stools of normal healthy donors who are highly screened, tested, and monitored in a clinically structured donation program.
Biological: CP101
Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
Also known as: Full-Spectrum Microbiota™
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Time frame: Up to Week 8
Occurence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 8
Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
Time frame: Up to Week 24
| Milestone | CP101 |
|---|---|
| Started | 132 |
| Completed | 123 |
| Not completed | 9 |
| Milestone | CP101 |
|---|---|
| Started | 123 |
| Completed | 112 |
| Not completed | 11 |
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
| Participants | CP101 |
|---|---|
| Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication | 106 |
| Participants | CP101 |
|---|---|
| Occurence of Treatment Emergent Adverse Events (TEAEs) | 88 |
Defined in the protocol as sustained clinical cure. Clinical cure means a patient did not experience a recurrence of C. diff during this time period.
| Participants | CP101 |
|---|---|
| Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication | 104 |
Collected over Up to Week 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CP101 | 1/132 (0.8%) | 17/132 (12.9%) | 97/132 (73.5%) |
| Event | CP101 |
|---|---|
| Cardiac failure congestiveCardiac disorders | 2/132 |
| NauseaGastrointestinal disorders | 2/132 |
| Clostridium difficile colitisInfections and infestations | 2/132 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 2/132 |
| AnaemiaBlood and lymphatic system disorders | 1/132 |
| Iron deficiency anaemiaBlood and lymphatic system disorders | 1/132 |
| Acute left ventricular failureCardiac disorders | 1/132 |
| Angina pectorisCardiac disorders | 1/132 |
| Atrial fibrillationCardiac disorders | 1/132 |
| Atrial flutterCardiac disorders | 1/132 |
| Event | CP101 |
|---|---|
| DiarrhoeaGastrointestinal disorders | 52/132 |
| Abdominal painGastrointestinal disorders | 43/132 |
| Defaecation urgencyGastrointestinal disorders | 33/132 |
| NauseaGastrointestinal disorders | 24/132 |
| Decreased appetiteMetabolism and nutrition disorders | 24/132 |
| Abdominal distensionGastrointestinal disorders | 23/132 |
| Abdominal tendernessGastrointestinal disorders | 17/132 |
| Anal incontinenceGastrointestinal disorders | 13/132 |
| VomitingGastrointestinal disorders | 12/132 |
| HaematocheziaGastrointestinal disorders | 10/132 |
Modified Intent to Treat (mITT) population
| Age, Continuous(Years) | CP101 |
|---|---|
| Mean | 66 ± 15.83 |
| Sex: Female, Male(Participants) | CP101 |
|---|---|
| Female | 99 |
| Male | 33 |
| Ethnicity (NIH/OMB)(Participants) | CP101 |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 126 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | CP101 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 127 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CP101 |
|---|---|
| Canada | 9 |
| United States | 123 |
| Total number of C. difficile Infection (CDI) episodes in previous 6 months(Participants) | CP101 |
|---|---|
| 1 | 2 |
| 2 | 44 |
| 3 | 49 |
| >3 | 37 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Dec 2020, 31 months.
Results were first posted in Aug 2022, 1 year 7 months after primary completion.
Of 23 phase 2 interventional studies under Clostridium Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 39. This study's 31 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fecal microbiota
Finch Research and Development LLC.