Nutritional Status in Children With Food Allergy: Evaluation of a New Supplement (ALLERGYSTOP)

EVALUATION OF A NEW SUPPLEMENT ON NUTRITIONAL STATUS IN CHILDREN WITH FOOD ALLERGY

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.

Study Overview

• Status: Completed
• Conditions: Food Allergies
• Intervention / Treatment: Other: Placebo; Dietary supplement: Food supplement

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples
    • Naples, Naples, Italy, 80131
      • Department of Traslational Medical Science - University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplement; Subjects assigned to receive the treatment	Dietary supplement: Food supplement; The nutritional composition of the food supplement comprises: sodium butyrate, inactivated Lactobacillus rhamnosus GG Perilla frutescens dry extract quercetin fructo-oligosaccharides Vitamin D3 omega 3 polyunsaturated acids
Placebo Comparator: Placebo; Subjects assigned to receive the placebo	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body growth parameters	body mass index	after 6 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical values	serum vitamin D levels	after 6 months of treatment
biochemical values	serum DHA levels	after 6 months of treatment
Cytokines production	Th2 cytokines (IL-4, IL-5, IL-13), IL-10 production	after 48 days
regulatory T cells (Tregs) production	regulatory T cells (Tregs)	after 4 days
regulatory dendritic cell markers production	regulatory dendritic cell markers (Tgfb1, Ifna2, Ptgs2, Csf2)	after 4 days

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 26, 2024
• First Posted (Actual): December 30, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: food allergy; allergy; cow milk protein allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: 09/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No