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

NCT07526558 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Post-tick Bite Illness
  • Mast Cell Stabilizer

Interventions

DRUG

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.

DRUG

fexofenadine

Fexofenadine is a second-generation H1 antihistamine administered orally at a dose of 180 mg once daily

DRUG

Cromolyn Sodium

Cromolyn sodium is a mast cell stabilizer administered orally at a dose of 200 mg three times daily.

Sponsors & Collaborators

Principal Investigators

  • Scott Commins · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07526558 on ClinicalTrials.gov