An observational study in Food Allergy, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by University Medical Centre Ljubljana · Observational
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:
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 130 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
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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).
Exclusion Criteria:
Children with milk allergy.
Biological: Blood sample analysis · Radiation: Bone mineral density measurement (DXA) · Other: Influence of food allergy on growth (intervention groups)
Children with egg allergy
Biological: Blood sample analysis · Other: Anthropometrics measurement - at inclusion to the study (all groups). · Other: Influence of food allergy on growth (intervention groups)
Children with peanut allergy
Biological: Blood sample analysis · Other: Anthropometrics measurement - at inclusion to the study (all groups). · Other: Influence of food allergy on growth (intervention groups)
Patients withhout food allergy (bee venom or drug allergy).
Biological: Blood sample analysis · Other: Anthropometrics measurement - at inclusion to the study (all groups).
Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.
Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.
Analysis of bone mineral density with DXA in patients with milk allegy. Analysis ordered by medical doctor.
Gathering the data about of body height (cm), weight (kg) BMI (kg/m2) at the diagnosis of food allergy and comparison versus data at the enrollment in the study to asses growth.
Influence of food allergy on growth
Patients body weight (kg), height (cm) and use WHO growth curves to asses their growth and nutritional status and compare the to control group. Comparison of their measurements against the measurements at the time od diagnosis to asses the influence on growth.
Time frame: 6 years
Influence of food allergy on food intake and nutrient intake
Patients caregivers will deliver 3 - day food diary and dietitan will analyse it (energy intake - kcals/KJ, intake of proteins kg/kg of body weight/day, intake of calcium and iron in mg/day and %of fat, %of carbohydrates and % of proteins in their nutrition. It will all be compared to the control group..
Time frame: 29 months
Influence of food allergy on blood sampling analysis
Blood sample analysis will be performed and results of intervention groups compared versus control group
Time frame: 29 months
Influence of milk allergy on bone mineral density
Data of bone mineral density will be gathered from our patients database and analysed
Time frame: 29 months
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University Medical Centre Ljubljana