D2.152 - Study design for the effect of SCIT on tic symptoms in Children and Adolescents with HDM aLlergy and coMorbid tic disorders: a multicenter prospective observational study (CALM study)
Background
Allergic diseases impact nearly one-third of the global population, leading to significant economic burdens, reduced quality of life, and mental health challenges. Recent studies have highlighted a connection between allergic diseases and tic disorders (TD). Currently, allergen immunotherapy (AIT) is the only treatment known to modify the progression of allergic diseases. This study aims to investigate the effect of subcutaneous immunotherapy (SCIT) on tic symptoms in Chinese children and adolescent patients with house dust Mite(HDM) allergy and comorbid TD.
Method
The CALM study is a multicenter prospective observational study involving four hospitals across China. It will enroll children and adolescents aged 5 to 18 who have a clinical diagnosis of HDM-induced allergy with comorbid TD. All participants will receive standard treatment for TD and will be divided into two groups: the SCIT group, which will receive SCIT using a native double-mite preparation, and the non-AIT group, which will receive only symptomatic treatment. The Yale Global Tic Severity Scale (YGTSS) will be used to assess tic symptoms, the VAS for allergic symptoms, and the PRQLQ to evaluate quality of life. Additionally, serum levels of microelements such as Vitamin D, iron, zinc, calcium, and ferritin will be tested.
Results
We hypothesize that the CALM study will demonstrate a significant improvement in the YGTSS scores for the SCIT group compared to the non-AIT group.
Conclusion
SCIT has the potential to alleviate tic symptoms in children and adolescents with HDM allergy and comorbid TD. Therefore, SCIT may be considered the first-line treatment option for patients with both HDM allergy and comorbid TD.
