All of Us Research Program
Site Principal Investigator: Pamela Pawloski, Pharm.D., BCOP, FCCP
Study sponsor: National Institutes of Health (NIH)
Locations:
-Regions Cancer Care Center
-HealthPartners Neuroscience Center
Purpose of study: HealthPartners Institute is part of the All of Us research program funded by the National Institutes of Health (NIH). The goal of the All of Us research program is to improve health for all of us, for generations to come. The research program is asking people across the United States to join and share their health information and other data to build a large research database that will inform future studies and may even help make the next big medical discovery.
If you are interested you can begin the enrollment process by creating an account online at JoinAllofUs.org/HP. This will give you access to the Participant Portal where you can learn more about the study, complete consent forms, take health surveys, and begin the All of Us journey. If you are eligible, you will be invited to attend an in-person visit at one of our HealthPartners enrollment clinics to have your physical measurements taken and provide blood and urine samples. You will receive a $25 gift card if you are eligible and complete a clinic visit.
Inclusion Criteria: Patients 18 years old or older, current resident of the U.S., not incarcerated
Study Contact:
(952) 967-6911
AllofUs@HealthPartners.com
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
