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Mast Cell Treatment in Post-tick Bite Illness (PTBI)
Sponsor: University of North Carolina, Chapel Hill
Summary
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).
Official title: A Phase II Pilot Study to Assess the Safety and Tolerability of Mast Cell Treatment in Post-tick Bite Illness
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-04-30
Completion Date
2027-01
Last Updated
2026-04-13
Healthy Volunteers
Yes
Interventions
Ketotifen
Ketotifen is a mast cell stabilizer and H1 antihistamine administered orally at 1 mg twice daily, with dose escalation to 2 mg twice daily after 30 days.
fexofenadine
Fexofenadine is a second-generation H1 antihistamine administered orally at a dose of 180 mg once daily
Cromolyn Sodium
Cromolyn sodium is a mast cell stabilizer administered orally at a dose of 200 mg three times daily.
Locations (1)
University of North Carolina
Chapel Hill, North Carolina, United States