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
Frequency of Ketosis in People Living with Diabetes or Other Medical Conditions
Principal Investigator: Richard Bergenstal, MD
Study Sponsor: Abbott Diabetes Care
Location: International Diabetes Center
Purpose of study: The purpose of this research study is to use the investigational FreeStyle Libre X Continuous Glucose Monitoring System to collect both ketone and glucose levels, and to learn about how often elevated ketones occur in adults and children living with diabetes and other medical conditions which may affect these levels. Ketones are acids made by the body when using fats for energy instead of carbohydrates. Study participation includes 2-3 appointments over a period of about 3-6 weeks.
Participants will receive:
– The study system to use during participation
– Compensation for completed visits and use of study diary
– Study related lab tests at no cost
Inclusion criteria:
You may qualify if you:
– Have diabetes:
- type 1 (ages 2 and up)
- type 2 diabetes
- gestational diabetes OR are pregnant and have type 1 or type 2 diabetes
– AND/OR have heart failure
– Meet other study specific requirements
Study Contact:
Caitlin Moening
(952) 993-9605
IDCResearch@parknicollet.com
