Probiotic oral immunotherapy for egg and milk allergy induces sustained unresponsiveness.

Background: High-dose rapid-escalation oral immunotherapy (OIT) with adjunct probiotic is effective at inducing sustained unresponsiveness (SU) of peanut allergy, but the efficacy of this approach for other food allergies is untested. This open-label study aimed to confirm the safety and tolerability of high-dose egg and milk oral immunotherapy (OIT) with probiotic in children.

Methods: Participants aged 5-17 years with egg (n = 20) or milk (n = 20) allergy confirmed by double-blind placebo-controlled food challenge (DBPCFC) received probiotic and either egg or milk OIT for 18 months. SU was assessed by DBPCFC performed post-treatment (after 8 weeks dietary allergen exclusion). The primary outcome was the proportion completing the dose-escalation phase according to protocol. Secondary outcomes were the proportion with SU, adverse events (AE), and change in health-related quality of life (HRQL).

Results: Nine (45%) egg and 7 (35%) milk participants completed the dose-escalation according to protocol, and 17 (85%) in both groups were able to reach the maintenance phase with dose modifications. Eleven (55%) egg and 10 (50%) milk participants attained SU. Treatment-related AEs were frequent, with 9 (45%) egg and 13 (65%) milk participants reporting at least one moderate or severe event. Clinically significant improvements in HRQL were observed in both groups.

Conclusion: High-dose rapid-escalation OIT with adjunct probiotic is a promising treatment for egg and milk allergy, which may increase the likelihood of achieving SU and shorten the required treatment period for participants. The efficacy and safety of this approach should be confirmed in later-stage placebo-controlled randomized trials.