Frequently Asked
Questions
What is a clinical trial?
A clinical trial is a research study that helps doctors learn if a new treatment is safe and effective. This clinical trial is testing CLF065 for people with chronic pouchitis after J-pouch surgery.
Why should someone consider participating in this clinical trial?
Participants may gain early access to a promising treatment, receive care from an experienced research team, and help advance care for others with pouchitis.
What is CLF065?
CLF065 is a long-acting investigational product being tested to see if it reduces inflammation and improves symptoms of chronic pouchitis.
What is a placebo?
A placebo looks like the investigational product but has no active ingredients. Using a placebo helps researchers evaluate how well the actual treatment works.
Will participants know which treatment they’re receiving?
No. This is a double-blind clinical trial, which means neither participants nor doctors will know who is receiving CLF065 or placebo.
Can participants leave the clinical trial at any time?
Yes. Participation is always voluntary. You may leave the clinical trial at any time for any reason.
Will participation in this clinical trial affect my regular care or medications?
Participants will continue to see their regular healthcare providers for non-study-related care. Certain medications like antibiotics or steroids may need to be paused or adjusted.
Is there any cost to join?
No. All study-related care, visits, and medications are provided at no cost.
How is privacy protected?
All personal health information is kept secure and confidential in accordance with HIPAA and research regulations.
How do I find out if I qualify?
Contact our clinical trial team. We’ll ask a few simple screening questions to determine if this clinical trial might be a good match.