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Keep this study
Lead
Finch Research and Development LLC.
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
