Food AllergyNCT04740632
The Quality of Life of Mothers of Children With Food Allergy
A study testing Personalized Nutritional Counseling by a multidisciplinary team in people with Food Allergy, run by Federico II University at 1 site in Italy.
Trial summary
Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Food Allergy
- What is being tested?
- Personalized Nutritional Counseling by a multidisciplinary team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult mother of a patient <12 years of age diagnosed with FA
Who cannot join
- 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
Show all 44Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, 80131
About this study
Official title: The Effects of Nutritional Counseling on Maternal Quality of Life of Children With Food Allergy
Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Prevalence, persistence and severity of pediatric FA have significantly increased over the past 2 decades. The treatment of FA is based on a rigorous elimination diet and on the correct management of acute allergic reactions, induced by the accidental ingestion of food allergens, with antihistamines, cortisones and adrenaline. Ensuring a strict exclusion of the allergen from the diet can be problematic, with the risk of nutritional deficiencies, accidental exposure, cross-contamination or caused by incorrect labeling of processed food products. At the same time, the daily management of a correct elimination diet and a possible allergic reaction, entail a significant burden and high levels of anxiety and stress associated with uncertainty about the management of anaphylaxis, in the parents of children with FA, particularly in mothers, resulting in an impact on Quality of Life (QoL). The availability of a multidisciplinary team made up of pediatricians, allergists and dietitians / nutritionists with experience in the field of FA could reduce the stress and anxiety of parents, while improving their QoL. Currently, for the evaluation of the quality of life of the parent of a child with FA, specific questionnaires for food allergies developed and validated in English are used: the food allergy self-efficacy scale for parents (FASE-P) and the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB).
- Conditions
- Food Allergy
- Being tested
- Personalized Nutritional Counseling by a multidisciplinary team
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Nutritional Counseling by a multidisciplinary teamBehavioural
Active diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes
| Study group | Role | What they receive |
|---|---|---|
| Mothers of children with food allergy diagnosed by a multidisciplinary team | No intervention | Mothers of children with food allergy diagnosed by a multidisciplinary team (Group 1) already followed for at least 6 months by the Tertiary Center of Pediatric Allergology.. |
| Mothers of children with food allergy diagnosed by a non-multidisciplinary team | Experimental | Mothers of children with food allergy diagnosed by a non-multidisciplinary team who plan to visit for the first time the Tertiary Center of Pediatric Allergology. Receives: Behavioral: Personalized Nutritional Counseling by a multidisciplinary team |
What is being measured
The primary outcome is the main question the study is designed to answer.
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
To explore potential differences at baseline (T0) in the quality of life, provided by the FASE-P questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
Measured: baseline
FAQL-PB
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQL-PB questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
Measured: baseline
FAQLQ-PF
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQLQ-PF questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
Measured: baseline
Secondary outcomes (12)
FASE-P Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FASE-P of Group 2 mothers; and minimun and maximum of the three specific questionnaires for food allergies administered to the patient's mother
Measured: 6 months
FAQL-PB Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQL-PB of Group 2 mothers.
Measured: 6 months
FAQLQ-PF Group 2
Evaluation after 6 months (T6) the effects of Nutritional Counseling on the FAQLQ-PF of Group 2 mothers.
Measured: 6 months
FASE-P at 6 months Group 2 versus Group 1
Compare after 6 months (T6) the FASE-P of Group 2 versus Group 1.
Measured: 6 months
FAQL-PB Group 2 versus Group 1
Compare after 6 months (T6) the FAQL-PB of Group 2 versus Group 1.
Measured: 6 months
FAQLQ-PF Group 2 versus Group 1
Compare after 6 months (T6) the FAQLQ-PF of Group 2 versus Group 1.
Measured: 6 months
Z-score weight for age Group 2
Z-score weight for age of the Group 2.
Measured: At baseline and at 6 months
Z-score length for age Group 2
Z-score length for age of the Group 2.
Measured: At baseline and at 6 months
Z-score BMI for age Group 2
Z-score BMI for age of the Group 2.
Measured: At baseline and at 6 months
Z-score weight for age Group 2 versus Group 1
Z-score weight for age of comparing the Group 1 and Group 2.
Measured: At baseline and at 6 months
Z-score length for age Group 2 versus Group 1
Z-score lenght for age of comparing the Group 1 and Group 2.
Measured: At baseline and at 6 months
Z-score BMI for age Group 2 versus Group 1
Z-score BMI for age of comparing the Group 1 and Group 2.
Measured: At baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start10 Jan 2022
- Primary completion10 Jun 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740632
- Sponsor's protocol ID
- 283/20
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nutritional Counseling on Maternal Quality of Life of Children With Food Allergy
- ClinicalTrials.gov ID
- NCT04740632
- Acronym / sponsor ID
- 283/20
- Conditions
- Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Prevalence, persistence and severity of pediatric FA have significantly increased over the past 2 decades. The treatment of FA is based on a rigorous elimination diet and on the correct management of acute allergic reactions, induced by the accidental ingestion of food allergens, with antihistamines, cortisones and adrenaline. Ensuring a strict exclusion of the allergen from the diet can be problematic, with the risk of nutritional deficiencies, accidental exposure, cross-contamination or caused by incorrect labeling of processed food products. At the same time, the daily management of a correct elimination diet and a possible allergic reaction, entail a significant burden and high levels of anxiety and stress associated with uncertainty about the management of anaphylaxis, in the parents of children with FA, particularly in mothers, resulting in an impact on Quality of Life (QoL). The availability of a multidisciplinary team made up of pediatricians, allergists and dietitians / nutritionists with experience in the field of FA could reduce the stress and anxiety of parents, while improving their QoL. Currently, for the evaluation of the quality of life of the parent of a child with FA, specific questionnaires for food allergies developed and validated in English are used: the food allergy self-efficacy scale for parents (FASE-P) and the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers of children with food allergy diagnosed by a multidisciplinary team | No intervention | –Mothers of children with food allergy diagnosed by a multidisciplinary team (Group 1) already followed for at least 6 months by the Tertiary Center of Pediatric Allergology.. |
| Mothers of children with food allergy diagnosed by a non-multidisciplinary team | Experimental | Behavioral: Personalized Nutritional Counseling by a multidisciplinary teamMothers of children with food allergy diagnosed by a non-multidisciplinary team who plan to visit for the first time the Tertiary Center of Pediatric Allergology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult mother of a patient <12 years of age diagnosed with FA
Key exclusion criteria (44 listed)
- Mother's age <18 years
- Mother unable to understand Italian
- Mother suffering from chronic diseases
- Mother suffering from epilepsy
- Mother suffering from neoplasms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Nutritional Counseling by a multidisciplinary teamActive diet therapy, instructions on reading labels, cross-contamination, allergen-free, foods recipes | Behavioural | Mothers of children with food allergy diagnosed by a non-multidisciplinary team |
Primary outcome
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
Time frame: baseline
To explore potential differences at baseline (T0) in the quality of life, provided by the FASE-P questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
FAQL-PB
Time frame: baseline
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQL-PB questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
FAQLQ-PF
Time frame: baseline
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQLQ-PF questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
12 secondary outcomes
FASE-P Group 2
Time frame: 6 months
FAQL-PB Group 2
Time frame: 6 months
FAQLQ-PF Group 2
Time frame: 6 months
FASE-P at 6 months Group 2 versus Group 1
Time frame: 6 months
FAQL-PB Group 2 versus Group 1
Time frame: 6 months
FAQLQ-PF Group 2 versus Group 1
Time frame: 6 months
Z-score weight for age Group 2
Time frame: At baseline and at 6 months
Z-score length for age Group 2
Time frame: At baseline and at 6 months
Z-score BMI for age Group 2
Time frame: At baseline and at 6 months
Z-score weight for age Group 2 versus Group 1
Time frame: At baseline and at 6 months
Z-score length for age Group 2 versus Group 1
Time frame: At baseline and at 6 months
Z-score BMI for age Group 2 versus Group 1
Time frame: At baseline and at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Nutritional Counseling by a multidisciplinary team in people with Food Allergy, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2). (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.