Mast Cell Treatment in Post-tick Bite Illness (PTBI)
United States50 participantsStarted 2026-04-30
Plain-language 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).
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion Criteria:
* In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Ability to understand and provide informed consent in English (a translator will not be present during screening, consent or follow-up visits)
* Age 21-65 years old and of any gender, race, and ethnicity at the time of the initial visit.
* History of Ehrlichiosis and/or Rocky Mountain Spotted Fever (RMSF) within the last 36 months diagnosed and treated by a healthcare provider more than 6 months previously with current symptoms causing clinically significant distress or impairment in functioning as measured by a mast cell symptom scale score \>88 ± 9
* OR - History of alpha-gal syndrome (AGS) with an alpha-gal Immunoglobulin E (IgE) \>0.1 IU/mL and managed on an appropriate avoidance diet for more than 6 months previously with current symptoms causing clinically significant distress or impairment in functioning as measured by a mast cell symptom scale score \>88 ± 9
* Females of childbearing potential must have a negative pregnancy test prior to study entry
* Ability to refrain from diphenhydramine ("Benadryl") during the study period
Exclusion Criteria:
* Any individual who meets one or more of the following criteria will be excluded from participation:
* History of allergy, intolerance or hypersensitivity to fexofenadine, cromolyn or ketotifen (as documented by self-report and/or medical chart review)
* History of a prior c…
What they're measuring
1
Change in Mast Cell Activation Symptom Score
Timeframe: Baseline, after 4 months of intervention