Mast Cell Treatment in Post-tick Bite Illness (PTBI) (NCT07526558)
A Phase II Pilot Study to Assess the Safety and Tolerability of Mast Cell Treatment in Post-tick Bite Illness
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase II double-blinded study to assess the safety, tolerability, and feasibility of the mast cell stabilizing medications ketotifen and cromolyn compared to participants receiving standard of care treatment with fexofenadine alone in participants who have persistent symptoms of mast cell activation following a documented tick-borne illness (Ehrlichiosis, Rocky Mountain Spotted Fever, Alpha-gal Syndrome).
Who can join: Review the eligibility criteria below.
Location: University of North Carolina — Chapel Hill, North Carolina
Age range: 21 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of North Carolina — Chapel Hill, North Carolina
📞 Contact the Study Coordinator
Phone: (919) 537-3306
Email: scommins@email.unc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Post-tick Bite Illness clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.