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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

For questions, contact:

Shilpa Karanjit
karanjit@email.unc.edu
(919) 843-8519
Visit Website

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

Gender Any

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

Compensation

$100 for screening, $100 for Randomization day visit, $75 for each clinic visit, and $75 for each additional safety visits if required by the PI

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.