Completed

ALLERGYSTOPNew Supplement on Nutritional Status in Children with Food Allergy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Food supplement

+ Placebo

Dietary SupplementOther
Who is being recruted

Food Hypersensitivity+1

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 36 to 60 Months
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorFederico II University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 30, 2024

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new supplement to help improve the nutritional status of children with food allergies. Food allergies are becoming more common, especially among young children, and are often challenging due to the need to avoid certain foods. This avoidance can lead to issues like poor growth and lack of essential nutrients. Since there is no FDA-approved treatment for food allergies, this study aims to find alternative ways to manage the nutritional challenges these children face, potentially offering better health outcomes and reducing the impact of strict dietary restrictions. In this study, children with food allergies will receive a new supplement. The children will be monitored to see if the supplement helps improve their nutritional status, which could involve assessing their growth, nutrient levels, and overall health. By measuring these factors, researchers hope to determine if the supplement can offer a beneficial alternative to current dietary management practices. There is no mention of specific risks or benefits in the study details, but the goal is to provide a safer and more effective way to support the nutritional needs of children with food allergies.

Official TitleEVALUATION OF A NEW SUPPLEMENT ON NUTRITIONAL STATUS IN CHILDREN WITH FOOD ALLERGY
Principal SponsorFederico II University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 36 to 60 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Food HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System Diseases

Criteria

7 inclusion criteria required to participate
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

Show More Criteria

3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Subjects assigned to receive the treatment

Group II

Placebo
Subjects assigned to receive the placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Traslational Medical Science - University of Naples Federico II

Naples, ItalyOpen Department of Traslational Medical Science - University of Naples Federico II in Google Maps
CompletedOne Study Center