Food AllergyNCT05937061
Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
An observational study of Food Allergy, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Blood sample analysis, Anthropometrics measurement - at inclusion to the study (all groups). and Bone mineral density measurement (DXA)
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 May 2019to 31 Dec 2022
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history)
Who cannot join
- other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),
- vegetarian or vegan nutrition.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Universitiy Medical center Ljubljana, division for Pediatrics
Ljubljana, 1000
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- Blood sample analysis, Anthropometrics measurement - at inclusion to the study (all groups)., Bone mineral density measurement (DXA), Influence of food allergy on growth (intervention groups)
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample analysisBiological
Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.
Anthropometrics measurement - at inclusion to the study (all groups).Other
Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.
Bone mineral density measurement (DXA)Radiation
Analysis of bone mineral density with DXA in patients with milk allegy. Analysis ordered by medical doctor.
Influence of food allergy on growth (intervention groups)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Milk allergy | Children with milk allergy. Receives: Biological: Blood sample analysis; Radiation: Bone mineral density measurement (DXA); Other: Influence of food allergy on growth (intervention groups) | |
| Egg Allergy | Children with egg allergy Receives: Biological: Blood sample analysis; Other: Anthropometrics measurement - at inclusion to the study (all groups).; Other: Influence of food allergy on growth (intervention groups) | |
| Peanut allergy | Children with peanut allergy Receives: Biological: Blood sample analysis; Other: Anthropometrics measurement - at inclusion to the study (all groups).; Other: Influence of food allergy on growth (intervention groups) | |
| Control group | Patients withhout food allergy (bee venom or drug allergy). Receives: Biological: Blood sample analysis; Other: Anthropometrics measurement - at inclusion to the study (all groups). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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..
Measured: 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
Measured: 29 months
Influence of milk allergy on bone mineral density
Data of bone mineral density will be gathered from our patients database and analysed
Measured: 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 May 2019
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tadej Avcin, prof., Study director, Head of Department of Clinical Immunology, Rheumatology and Allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937061
- Sponsor's protocol ID
- 20200133
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24933388Beck 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.
PubMed 26441150Meyer 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.
PubMed 27418957Mailhot 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.
PubMed 27244780Robbins 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.
PubMed 25312758Kim 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.
PubMed 24353835
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
- ClinicalTrials.gov ID
- NCT05937061
- Acronym / sponsor ID
- 20200133
- Conditions
- Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Jul 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk allergy | – | Biological: Blood sample analysis, Radiation: Bone mineral density measurement (DXA), Other: Influence of food allergy on growth (intervention groups)Children with milk allergy. |
| 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 egg allergy |
| 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)Children with peanut allergy |
| Control group | – | Biological: Blood sample analysis, Other: Anthropometrics measurement - at inclusion to the study (all groups).Patients withhout food allergy (bee venom or drug allergy). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (1 listed)
- IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history)
Key exclusion criteria (2 listed)
- other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),
- vegetarian or vegan nutrition.
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 |
|---|---|---|
| Blood sample analysisAnalysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control. | Biological | Control group, Egg Allergy, Milk allergy, Peanut allergy |
| Anthropometrics measurement - at inclusion to the study (all groups).Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control. | Other | Control group, Egg Allergy, Peanut allergy |
| Bone mineral density measurement (DXA)Analysis of bone mineral density with DXA in patients with milk allegy. Analysis ordered by medical doctor. | Radiation | Milk allergy |
| Influence of food allergy on growth (intervention groups)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. | Other | Egg Allergy, Milk allergy, Peanut allergy |
Primary outcome
Influence of food allergy on growth
Time frame: 6 years
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.
Influence of food allergy on food intake and nutrient intake
Time frame: 29 months
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..
Influence of food allergy on blood sampling analysis
Time frame: 29 months
Blood sample analysis will be performed and results of intervention groups compared versus control group
Influence of milk allergy on bone mineral density
Time frame: 29 months
Data of bone mineral density will be gathered from our patients database and analysed
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 10 Jul 2023.
- Background: PubMed 24933388Berni 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.
- Background: PubMed 26441150Beck 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.
- Background: PubMed 27418957Meyer 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.
- Background: PubMed 27244780Mailhot 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.
- Background: PubMed 25312758Robbins 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.
- Background: PubMed 24353835Kim 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.
- Individual participant dataSharing planned: No
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
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.
Tadej Avcin, prof. study director
Head of Department of Clinical Immunology, Rheumatology and Allergology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 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 10 Jul 2023. 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 Slovenia. 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?
Influence of food allergy on growth (time frame: 6 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937061, which also lists 6 linked publications.
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 10 Jul 2023.