Finch CDI-001 Prism 3
University of North Carolina at Chapel Hill
Description
The purpose of this research study is to evaluate effectiveness and potential side effects of taking the test medicine versus a placebo to prevent recurrent Clostridium difficile infection (CDI). The test medicine, CP101, has not been approved by the FDA to treat or prevent recurrent CDI; its use in this study is investigational. By comparing people's responses to the placebo and to the test medicine being studied, researchers can tell whether the test medicine is having any benefit to prevent recurrent CDI.
Keywords:
Digestion, Microbiome, Stomach
Category:
Drug or Biologic
Phase:2
Qualifications
Age
18 - 99 years
Gender
Any
Study Population
Approximately 200 subjects 18 years of age or older, who experience recurrent Clostridium difficle infection (CDI), and who respond to a standard-of-care CDI antibiotic regimen for the most recent CDI episode will be randomized to study drug.
Investigator
Sarah McGill
Clinical Assistant Professor
Medicine-Gastroenterology
Recruitment Period End
December 31, 2020
Location
Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA
Study Qualifications
Age Range 18 - 99 years
Participant qualification(s) 1. Ability to provide written consent. 2. 18 years or older. 3. Have recurrent C. difficile infection (CDI).
Not eligible if: 1. Personal history of : • Crohn's disease or Ulcerative Colitis • IBS-D (irritable bowel syndrome with diarrhea) • Celiac disease, bile salt diarrhea, chronic pancreatitis, or short gut syndrome • HIV infection • Megacolon or ileus of the intestines 2. Have recently been in another drug or device study. 3. Had surgery on your digestive system (such as stomach or intestines). 4. Receiving chemotherapy or radiotherapy for cancer. 5. Pregnant, breastfeeding or considering becoming pregnant during the study period.
Number of Visits
- » 7 In person visit(s)
1 Screening, 1 Randomization, and 5 Clinic visits
» 6 Remote visit(s)6 Telephone Follow-Up
Participation Period
6 months
