Skip to main content
OpenTrials
Completed

NCT Number: NCT06751810

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

36 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food supplement

Dietary 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

Other

Placebo

Primary outcomes

  1. body growth parameters

    Time frame: after 6 months of treatment

    body mass index

Secondary outcomes

  1. biochemical values

    Time frame: after 6 months of treatment

    serum vitamin D levels

  2. biochemical values

    Time frame: after 6 months of treatment

    serum DHA levels

  3. Cytokines production

    Time frame: after 48 days

    Th2 cytokines (IL-4, IL-5, IL-13), IL-10 production

  4. regulatory T cells (Tregs) production

    Time frame: after 4 days

    regulatory T cells (Tregs)

  5. regulatory dendritic cell markers production

    Time frame: after 4 days

    regulatory dendritic cell markers (Tgfb1, Ifna2, Ptgs2, Csf2)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: ALLERGYSTOP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.