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Keep this study
Lead
Finch Research and Development LLC.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability to provide written informed consent
Men or women over 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
History of recurrent CDI defined as:
* ≥ 3 episodes of CDI, with 2 episodes occurring within the previous 6 months (inclusive of the current episode); OR
For the Qualifying CDI episode, the following criteria must be satisfied:
* History of diarrhea (\> 3 unformed stools per day) for 2 or more consecutive days that is clinically consistent with CDI. AND
* Documented positive stool test by local laboratory for toxigenic C. difficile (toxin enzyme immunoassay \[EIA\] or polymerase chain reaction \[PCR\]-based testing) for the current CDI episode and within 45 days prior to Randomization. AND
* Received a course of SOC CDI antibiotics for the most recent CDI episode (for 10 to 21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator). AND
* Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24 hours for 2 or more consecutive days during SOC CDI antibiotics prior to Randomization.
You may not be if
Known stool sample testing positive for enteric pathogen(s) (e.g., Salmonella, Shigella, diarrhoeagenic E. coli, Campylobacter, Giardia) within 28 days prior to Screening
Pregnant, breast-feeding, or planning to become pregnant during the trial
Historical or current diagnosis of inflammatory bowel disease
Recent diagnosis (\<6 months prior to screening) of diarrhea-predominant irritable bowel syndrome (post-infection or non-related to an enteric infection)
Initiation of any systemic cancer treatment (e.g., chemotherapy, radiotherapy, biologic, immunotherapy, others) for active malignancy
Major intra-abdominal surgery (e.g., bowel resection)
Known primary or secondary immunodeficiency
Clareo Health | A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
