Mast Cell Treatment in Post-tick Bite Illness (PTBI)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07526558
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Mast Cell Stabilizer
  • Post-tick Bite Illness

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ketotifen — DRUG
    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 — DRUG
    Fexofenadine is a second-generation H1 antihistamine administered orally at a dose of 180 mg once daily
  • Cromolyn Sodium — DRUG
    Cromolyn sodium is a mast cell stabilizer administered orally at a dose of 200 mg three times daily.

Study Details

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).

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fexofenadine Monotherapy
    Participants receive fexofenadine 180 mg orally once daily for 4 months following a 14-day open-label run-in period
  • Experimental: Mast Cell-Directed Combination Therapy
    Participants receive ketotifen plus cromolyn plus fexofenadine for 4 months following a 14-day open-label run-in period. Ketotifen is administered orally at 1 mg twice daily with dose escalation to 2 mg twice daily after 30 days. Cromolyn is administered orally at 200 mg three times daily, and fexofenadine is administered orally at 180 mg once daily.

Primary Outcome Measure

Change in Mast Cell Activation Symptom Score [ Time Frame: Baseline, after 4 months of intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27514
Study Coordinator
[email protected]
800-594-8624

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By research site
University of North Carolina· Chapel Hill, NC