Clinical trial NCT05937061: Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
Official title: Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 130
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with food-allergy were between 2 and 12 years old. All children in intervention group had IgE-mediated food allergy (skin prick test and/or speciﬁc IgE combined with an allergy focused history) to milk, egg or peanut.

In control group there were children between 2 and 12 years old, with no food allergy (patients with bee venom or drug allergy).

Brief summary: The goal of this single center retrospective cohort study with observational longitudinal follow up is to compare food - allergic children (egg, milk and peanut allergy) with children in control group (children without any food allergy).

The main question\[s\] it aims to answer are:

* If children with food allergy groups will have lower food intake od micronutrients?
* If growth in children with food allergy is worse as in control group?
* If they are more malnourished and in the food allergies group is more stunting than in the control group?
* If children with milk allergy have lower intake of calcium in their diet and lower mineral bone density?

Participants will be asked to do 3 day food diary and to have blood analysed (hemograme, complete blood count, serum iron status, serum protein).

If there is a comparison group: Researchers will compare milk, egg and peanut allergy group to the control group (peers without food allergy) to see if the food allergy affects growth, macronutrient, micronutrient intake.

Detailed description: Study design A single center retrospective cohort study with observational longitudinal follow up will be performed. The study will include three intervention groups (milk, egg and peanut allergy) and a control group (children with no food allergy). Patients will be 2 to 12 years old. The patients will be recruited at our University Medical Center Ljubljana, Pediatric hospital Ljubljana, outpatient care of our Department for Allergology, Rheumatology and Clinical Immunology. This study will be conducted according to the guidelines in Declaration of Helsinki and approved by Ethics Committee of Slovenia. Written informed consent will be obtained from all the subject's caregivers. The investigators will follow patients from confirmation of food allergy on and will collect data about their weight (kg) and height (cm) from our information system or patients' doctor (or caregiver). The investigators will collect data prospectively for 3 months from outpatient registry of our clinic. At the day of appointment patients will bring 3-day nutrition diary which was later analyzed by dietitian. The parents will attend an appointment by the dietitian where they will be informed about food diary analysis result and given the advice to enhance nutrition if necessary.

Eligibility criteria: Inclusion Criteria:

* IgE-mediated food allergy (skin prick test and/or speciﬁc IgE combined with an allergy focused history)

Exclusion Criteria:

* other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),
* vegetarian or vegan nutrition.

Primary outcomes:
measure: Influence of food allergy on growth
timeFrame: 6 years
measure: Influence of food allergy on food intake and nutrient intake
timeFrame: 29 months
measure: Influence of food allergy on blood sampling analysis
timeFrame: 29 months
measure: Influence of milk allergy on bone mineral density
timeFrame: 29 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Universitiy Medical center Ljubljana, division for Pediatrics
Study officials:
affiliation: Head of Department of Clinical Immunology, Rheumatology and Allergology
name: Tadej Avcin, prof.
role: STUDY_DIRECTOR
References:
citation: Berni Canani R, Leone L, D'Auria E, Riva E, Nocerino R, Ruotolo S, Terrin G, Cosenza L, Di Costanzo M, Passariello A, Coruzzo A, Agostoni C, Giovannini M, Troncone R. The effects of dietary counseling on children with food allergy: a prospective, multicenter intervention study. J Acad Nutr Diet. 2014 Sep;114(9):1432-9. doi: 10.1016/j.jand.2014.03.018. Epub 2014 Jun 3.
citation: Beck C, Koplin J, Dharmage S, Wake M, Gurrin L, McWilliam V, Tang M, Sun C, Foskey R, Allen KJ; HealthNuts Investigators. Persistent Food Allergy and Food Allergy Coexistent with Eczema Is Associated with Reduced Growth in the First 4 Years of Life. J Allergy Clin Immunol Pract. 2016 Mar-Apr;4(2):248-56.e3. doi: 10.1016/j.jaip.2015.08.009. Epub 2015 Oct 2.
citation: Meyer R, De Koker C, Dziubak R, Godwin H, Dominguez-Ortega G, Chebar Lozinsky A, Skrapac AK, Gholmie Y, Reeve K, Shah N. The impact of the elimination diet on growth and nutrient intake in children with food protein induced gastrointestinal allergies. Clin Transl Allergy. 2016 Jul 14;6:25. doi: 10.1186/s13601-016-0115-x. eCollection 2016.
citation: Mailhot G, Perrone V, Alos N, Dubois J, Delvin E, Paradis L, Des Roches A. Cow's Milk Allergy and Bone Mineral Density in Prepubertal Children. Pediatrics. 2016 May;137(5):e20151742. doi: 10.1542/peds.2015-1742.
citation: Robbins KA, Wood RA, Keet CA. Milk allergy is associated with decreased growth in US children. J Allergy Clin Immunol. 2014 Dec;134(6):1466-1468.e6. doi: 10.1016/j.jaci.2014.08.037. Epub 2014 Oct 11. No abstract available.
citation: Kim J, Kwon J, Noh G, Lee SS. The effects of elimination diet on nutritional status in subjects with atopic dermatitis. Nutr Res Pract. 2013 Dec;7(6):488-94. doi: 10.4162/nrp.2013.7.6.488. Epub 2013 Nov 29.