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

NCT06751810 | Completed

• 1 other identifier: 09/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergies

Keywords

allergy; food allergy; cow milk protein allergy

Outcome Measures

Primary Outcomes (1)

• body growth parameters

  body mass index

  after 6 months of treatment

Secondary Outcomes (5)

• 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

Study Arms (2)

Supplement

EXPERIMENTAL

Subjects assigned to receive the treatment

Dietary Supplement: Food supplement

Placebo

PLACEBO COMPARATOR

Subjects assigned to receive the placebo

Other: Placebo

Interventions

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

Supplement

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 36 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, Naples, 80131, Italy

Location

Related Publications (1)

• Carucci L, Caldaria E, Oglio F, Iorio RF, Mauriello V, Masino A, Coppola S. Immunonutritional effects elicited by a novel multicomponent food supplement in children with cow's milk allergy: results from a randomized, placebo-controlled trial. Front Allergy. 2026 Mar 16;7:1760231. doi: 10.3389/falgy.2026.1760231. eCollection 2026.

  PMID: 41918962 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD, Principal Investigator

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 30, 2024
• Study Start: December 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)