EVALUATION OF A NEW SUPPLEMENT ON NUTRITIONAL STATUS IN CHILDREN WITH FOOD ALLERGY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- body growth parameters
研究概览
简要总结
Allergic diseases are rising globally. By 2025, over half of the European population is projected to be affected by some form of allergy, with the highest rates among infants and young children. This growing prevalence also has a significant economic impact, resulting in more than 100 million lost work and school days each year due to allergic conditions.
Allergies arise from a breakdown in immune tolerance mechanisms. Current research suggests that the development is influenced by genetic, environmental, and gene-environment interactions, leading to immune system dysfunction, partly mediated by epigenetic mechanisms. Various factors have been proposed as contributors to FA onset. Among the unchangeable risk factors are male sex, race/ethnicity (with higher risks among Asian and Black children compared to White children), and genetics (familial associations, HLA, and specific genes).
Modifiable risk factors also play a role, with growing evidence showing that environmental influences, such as the use of antibiotics, antiseptic agents, and a high-fat, low-fiber diet, negatively affect microbiome composition. Additional risk factors potentially affecting FA onset include atopic diseases (such as comorbid atopic dermatitis), increased hygiene, vitamin D deficiency, reduced consumption of omega-3 polyunsaturated fatty acids and antioxidants, the use of antacids (which hinder the digestion of allergens), obesity, and the timing and route of food exposure (increased risk with delayed oral ingestion of allergens coupled with environmental exposure). The microbiome also plays a critical role in these processes.
Currently, no Food and Drug Administration (FDA)-approved treatment exists for FA, and the standard approach is strict dietary avoidance of the triggering allergens. As a result, the nutritional burden of elimination diets can be substantial, leading to risks such as growth failure, micronutrient deficiencies, and feeding challenges with long-term consequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with food allergy
- •Gestational age ≥ 37 weeks
- •Stable clinical condition and free from any symptoms possibly related to food allergy at least four weeks prior to study enrollment
- •Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
- •Parent(s) or legal guardian agrees not to enroll infant or child in another interventional clinical study while participating in this study
- •Written informed consent obtained from at least one parent (or legally acceptable representative [LAR], if applicable)
- •Infant or child's parent(s) / LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol
排除标准
- •other concomitant diseases
- •Infant or child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the infant or child inappropriate for entry into the study.
- •Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
结局指标
主要结局
body growth parameters
时间窗: after 6 months of treatment
body mass index
次要结局
- biochemical values(after 6 months of treatment)
- biochemical values(after 6 months of treatment)
- Cytokines production(after 48 days)
- regulatory T cells (Tregs) production(after 4 days)
- regulatory dendritic cell markers production(after 4 days)
研究者
Roberto Berni Canani, MD, PhD
Md, PhD, Principal Investigator
Federico II University