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

NCT ID: NCT06751810

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Supplement

Subjects assigned to receive the treatment

Group Type: EXPERIMENTAL

Food supplement

Intervention Type: 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

Subjects assigned to receive the placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

Md, PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, Naples, Italy

Countries

Italy

Other Identifiers

09/24

Identifier Type: -

Identifier Source: org_study_id