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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06751810
Acronym
ALLERGYSTOP
Enrollment
30
Registered
2024-12-30
Start date
2024-12-30
Completion date
2025-10-31
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergies

Keywords

allergy, food allergy, cow milk protein allergy

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.

Interventions

DIETARY_SUPPLEMENTFood 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

OTHERPlacebo

Placebo

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
36 Months to 60 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
body growth parametersafter 6 months of treatmentbody mass index

Secondary

MeasureTime frameDescription
biochemical valuesafter 6 months of treatmentserum vitamin D levels
Cytokines productionafter 48 daysTh2 cytokines (IL-4, IL-5, IL-13), IL-10 production
regulatory T cells (Tregs) productionafter 4 daysregulatory T cells (Tregs)
regulatory dendritic cell markers productionafter 4 daysregulatory dendritic cell markers (Tgfb1, Ifna2, Ptgs2, Csf2)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026