New hope for Tick-Bite survivors: mast cell drugs aim to ease lingering symptoms

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 course of ketotifen and/or cromolyn within 12 months before enrollment * Inability or unwillingness to give written informed consent or comply with study protocol * Pregnant (urine testing) or planning to become pregnant during the course of this study * Use of omalizumab within 6 months of enrollment * Use of systemic steroids for any reason within 28 days of study entry * Use of zileuton within 14 days of study entry * Have past or current medical problems or findings from physical exam or laboratory testing not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study or which may interfere with the ability to comply with study requirements * Suicidal ideation with intent in the last 6 months or suicidal behavior in the last year as assessed by the Columbia-suicide severity rating scale * Current serious unstable medical illness * Ongoing or planned other therapies to address post-tick bite illness (PTBI) symptoms during the course of this study