Oral Immunotherapy in Children with Cow's Milk Allergy: Clinical Efficacy and Psychosocial Impact in a Randomized Controlled Trial.

BACKGROUND

Cow's milk allergy (CMA) is a common food allergy in children and may substantial affect health, nutrition, and family quality of life (QoL). Oral immunotherapy (OIT) has emerged as a promising therapeutic approach for inducing desensitization; however, data on its effectiveness and impact on family QoL in Indonesia remain limited. This study aimed to evaluate the effectiveness of cow's milk OIT in achieving clinical desensitization, assess immunological changes in allergic reactivity, and analyze its impact on the QoL of families of children with CMA.

METHODS

This randomized, controlled, parallel-group clinical trial included children aged 1-12 years with IgE-mediated CMA. Participants were randomly assigned to either the cow's milk OIT group or the control group. The primary outcome was clinical desensitization, defined as the ability to tolerate 150-200 mL of cow's milk. Secondary outcomes included changes in skin prick test (SPT) wheal diameter and impact on family QoL as measured using the Food Allergy Impact Scale (FAIS).

RESULTS

Clinical desensitization was achieved by 84% of participants in the OIT group (21/25), whereas no participants in the control group achieved desensitization (p < 0.001). The mean final tolerated dose was significantly higher in the OIT group than in the control group (188.4 ± 27.53 mL vs 46.6 ± 6.73 mL; p <0.001), with a mean time to desensitization of 22.24 ± 2.96 weeks. SPT wheal diameter decreased significantly in the OIT group (from 5.24 ± 0.78 mm to 3.81 ± 0.88 mm; p <0.001), with no significant change in the control group (p = 0.614). Allergic reactions occurred in 70% of OIT participants; however, most were mild to moderate and were managed without serious adverse events. Rhinorrhea was more frequent in the OIT group (60% vs 0%; p <0.001). Total FAIS scores decreased significantly in the OIT group (z = -4.947; p <0.001), with improvements across most domains. MANOVA demonstrated a strong effect of OIT across all FAIS domains (Pillai's Trace = 0.711-0.892; F = 57.846-193.774; p <0.001). A history of eczema was negatively associated with desensitization success (OR = 0.059; 95% CI = 0.010-0.358; p = 0.002), whereas child age was positively associated with success (OR = 4.893; 95% CI = 1.171-20.443; p = 0.030).

CONCLUSION

Cow's milk OIT effectively improved clinical tolerance, reduced allergic reactivity, and enhanced family QoL among children with CMA. These findings support the implementation of OIT in clinical practice in Indonesia through individualized treatment and structured monitoring.