Clinical trial NCT06751810: Nutritional Status in Children with Food Allergy: Evaluation of a New Supplement
Official title: EVALUATION of a NEW SUPPLEMENT on NUTRITIONAL STATUS in CHILDREN with FOOD ALLERGY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Food Allergies
Keywords: allergy
food allergy
cow milk protein allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

  * Infants and children between 6 and 36 months of age

Primary outcomes:
measure: body growth parameters
timeFrame: after 6 months of treatment
Secondary outcomes:
measure: biochemical values
timeFrame: after 6 months of treatment
measure: biochemical values
timeFrame: after 6 months of treatment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References: