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Does a nutrition expert team ease the burden on mothers of kids with food allergies?

NCT ID NCT04740632

Symptom relief Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study tests whether personalized nutritional counseling from a team of pediatricians, allergists, and dietitians can improve the quality of life for mothers of children with food allergies. Researchers will compare mothers already receiving this multidisciplinary care with those who have not yet received it. They will use questionnaires to measure anxiety, stress, and daily burden. The goal is to see if expert guidance helps families manage elimination diets and reduce parental worry.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Personalized nutritional counseling by a multidisciplinary team
What this could lead to
If it works, this could show that structured nutritional counseling reduces stress and improves quality of life for mothers managing a child's food allergy.
What could go wrong
This is an early, non-randomized comparison, so differences between groups might stem from other factors. The study relies on questionnaires, not clinical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult mother of a patient \<12 years of age diagnosed with FA Exclusion Criteria: * Mother's age \<18 years * Mother unable to understand Italian * Mother suffering from chronic diseases * Mother suffering from epilepsy * Mother suffering from neoplasms * Mother suffering from immunodeficiencies * Mother suffering from chronic infections * Mother suffering from autoimmune diseases * Mother suffering from inflammatory bowel diseases * Mother suffering from functional gastrointestinal disorders * Mother suffering from celiac disease * Mother suffering from genetic-metabolic diseases * Mother suffering from tuberculosis * Mother suffering from congenital heart disease * Mother suffering from tuberculosis * Mother suffering from cystic fibrosis * Mother suffering from other chronic pulmonary diseases * Mother suffering from major malformations * Mother suffering from previous surgery of the cardiovascular / respiratory / gastrointestinal tract * Mother suffering from diabetes * Mother suffering from neuropsychiatric and neurological disorders * Mother suffering from eosinophilic disorders of the gastrointestinal tract * Mother not living with her child with FA * Concomitant presence in the child with FA of chronic diseases * Concomitant presence in the child with FA of epilepsy * Concomitant presence in the child with FA of neoplasms * Concomitant presence in the child with FA of immunodeficiencies * Concomitant presence in the child with FA of chronic infections * Concomitant presence in the child with FA of autoimmune diseases * Concomitant presence in the child with FA of inflammatory bowel diseases * Concomitant presence in the child with FA of functional gastrointestinal disorders * Concomitant presence in the child with FA of celiac disease * Concomitant presence in the child with FA of genetic-metabolic diseases * Concomitant presence in the child with FA of tuberculosis * Concomitant presence in the child with FA of congenital heart disease * Concomitant presence in the child with FA of tuberculosis * Concomitant presence in the child with FA of cystic fibrosis * Concomitant presence in the child with FA of other chronic lung diseases * Concomitant presence in the child with FA of major malformations * Concomitant presence in the child with FA of previous surgeries of the cardiovascular / respiratory / gastrointestinal tract * Concomitant presence in the child with FA of diabetes * Concomitant presence in the child with FA of neuropsychiatric and neurological disorders * Concomitant presence in the child with FA of eosinophilic diseases of the gastrointestinal tract * Concomitant presence in the child with FA of allergic diseases other than FA.

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Conditions

The condition(s) this trial relates to.

food allergy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Food allergy

Contacts and locations

Locations

  • Department of Traslational Medical Science - University of Naples Federico II

    Naples, Naples, 80131, Italy

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