Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum Microbiota (CP101) in Subjects with Recurrent C. Diff
Principal Investigator: Sandeep Bahadur, MD
Study Sponsor: Finch Pharmaceuticals
Location: HealthPartners Specialty Center
Phase of Study: Phase 2
Purpose of Study: The CP101 study is looking at the safety, efficacy, and tolerability of an oral fecal matter transplant (FMT) for patients with recurrent Clostridium Difficile Infection (C.Diff) (>2 recurrences). Eligible patients are randomized to receive either a placebo, low-dose FMT, or high-dose FMT. Patients are then followed for the next 24 weeks for safety measures and C.Diff recurrences.
Inclusion Criteria:
– 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 a standard course of oral vancomycin therapy to treat the current episode of recurrent CDI
Exclusion Criteria:
– 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 irritable bowel syndrome (IBS), or currently meets Rome III criteria for IBS
– Systemic chemotherapy for the treatment of cancer during the 60 days prior to consent or planned during the study
– Prior fecal transplant for any condition, regardless of route of administration
– Presence of ileostomy or colostomy, or history of prior gastric resection or significant colon resection
– Planned hospitalization or invasive surgery during the study
– Severe acute illness unrelated to CDI
Study Contact:
Jenny Koops
(651) 254-5316
Jenny.J.Kooops@HealthPartners.com
