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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Months - 48 Months
Gender	All

More Inclusion & Exclusion 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.

- Infants and children between 6 and 36 months of age

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06751810
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Federico II University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergies

Arms & Interventions

Arms

Experimental: Supplement

Subjects assigned to receive the treatment

Placebo Comparator: Placebo

Subjects assigned to receive the placebo

Interventions

Dietary Supplement: - Food supplement

The nutritional composition of the food supplement comprises: (i) butyric acid or butyrate, (ii)inactivated Lactobacillus rhamnosus GG (iii) a Perilla frutescens dry extract, and (iv) quercetin.

Other: - Placebo

Placebo

Contact a Trial Team

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International Sites

Naples, Italy

Status

Address

Department of Traslational Medical Science - University of Naples Federico II

Naples, , 80131

Site Contact

[email protected]

00817462680

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