Food AllergyNCT04312438
Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy
A study testing oral food challenge with cow's milk proteins in people with Food Allergy, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The aim of the study is to assess the safety of an oral food challenge (OFC) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet. Read more about this study
- Who is it for?
- Ages 13 months to 15 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- oral food challenge with cow's milk proteins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2020to Mar 2022
- 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 13 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged from 13 months to 15 years
- children diagnosed with cow's milk allergy treated with a dairy-free diet
- informed consent of the child's parents/legal guardians to participate in the study
Who cannot join
- occurrence of anaphylactic reaction after ingestion cow's milk proteins less than 12 months
- positive skin prick test with cow's milk proteins
- milk specific serum IgE values > 17,5 kU/L
- age below 13 moths
- no consent of the child's parents/legal guardians to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Wroclaw Medical University
Wroclaw, 50-367
Tatiana Jamer, PhD, +48 508 124 186, tatiana.jamer@umed.wroc.pl
Agnieszka Borys-Iwanicka, PhD, +48 692 082 313, agnieszka.borys-iwanicka@umed.wroc.pl
About this study
The aim of the study is to assess the safety of an oral food challenge (OFC) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet.
Read the detailed description
The aim of the study is to assess the safety of an oral food challenge test with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with food allergies after introducing cow's milk into the diet.
The study covers children over 12 months of age diagnosed with cow's milk allergy, treated with a non-dairy elimination diet based on extensively-hydrolyzed formulas or amino acid formulas, admitted to the Department of Pediatrics, Gastroenterology and Nutrition to conduct an open oral food challenge. In all children, after appropriate assessment and qualification (interview, physical examination, skin prick tests, results of allergen - specific immunoglobulin E (IgE), total blood count, fecal calprotectin and lactoferrin), an oral food challenge test with cow's milk will be performed. The oral food challenge test will be carried out in accordance with current standards and with child protection in the event of an adverse reactions. During the food challenge test (first 24 hours), after 2 weeks (phone survey) and 3 months after the test (visit to the Department) the frequency, severity and type of allergic reactions and cow's milk protein tolerance will be assessed. The safety of oral food challenge with cow's milk protein in children previously fed with extensively - hydrolyzed formulas or amino acid formulas will be compared. The results of allergy tests, total blood count and intestinal inflammatory markers (fecal calprotectin and fecal lactoferrin) will also be assessed before and 12 weeks after oral food challenge. The assessment of the incidence and severity of allergic reactions and tolerance of cow's milk proteins after introduction into the diet in children challenged with cow's milk proteins may help to establish guidelines on the qualifications and how to conduct an oral challenge test.
- Conditions
- Food Allergy
- Being tested
- oral food challenge with cow's milk proteins
- Keywords
- oral food challenge, food allergy, children
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral food challenge with cow's milk proteinsDiagnostic test
in children with diagnosed Cow's Milk Allergy open oral food challenge test with cow's milk protein (milk formula in children up to 3 yo, cow,s milk after 3 yo) will be carried out
| Study group | Role | What they receive |
|---|---|---|
| 13 mo to 15 yo children diagnosed with Cow's Milk Allergy | Experimental | oral food challenge with cow's milk proteins Receives: Diagnostic Test: oral food challenge with cow's milk proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of allergic reaction during and after oral food challenge assessed by the occurrence of allergic symptoms in children
assessment of type, severity and frequency of food allergy symptoms (allergic skin changes, gastrointestinal and respiratory tract symptoms) that occurred during and after oral food challenge, based on medical history data and physical examination collected by a doctor
Measured: up to 12 weeks after oral food challenge
Change of hemoglobin level after 12 weeks after oral food challenge
hemoglobin concentration in venous blood measured in g/dl
Measured: before and 12 weeks after oral food challenge
Changes in skin prick test results 12 weeks after oral food challenge
skin prick test with milk, egg yolk, egg white, chicken, wheat, fish before and 12 weeks after oral food challenge
Measured: before and 12 weeks after oral food challenge
Changes in allergen - specific IgE pediatric panel results 12 weeks after oral food challenge
allergen - specific IgE pediatric panel results (allergen - specific IgE concentration measured in kU/l, classified in grades 0-6) before and 12 weeks after oral food challenge
Measured: before and 12 weeks after oral food challenge
Change of fecal calprotectin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge
concentration of fecal calprotectin in the feces measured in ug/g before and 12 weeks afte oral food challenge
Measured: before and 12 weeks after oral food challenge
Change of fecal lactoferrin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge
concentration of fecal lactoferrin in the feces measured in μg/g before and 12 weeks afte oral food challenge
Measured: before and 12 weeks after oral food challenge
Secondary outcomes (3)
Comparison of the incidence of allergic reaction during and after oral food challenge with cow's milk protein between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
assessment of type, severity and frequency of food allergy symptoms (allergic skin changes, gastrointestinal and respiratory tract symptoms) that occurred during and after oral food challenge, based on medical history data and physical examination collected by a doctor
Measured: up to 12 weeks after oral food challenge
Comparison of changes in skin prick test results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
skin prick test with milk, egg yolk, egg white, chicken, wheat, fish before and 12 weeks after oral food challenge
Measured: before and 12 weeks after oral food challenge
comparison of changes in allergen - specific IgE pediatric panel results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
allergen - specific IgE pediatric panel results (allergen - specific IgE concentration measured in kU/l, classified in grades 0-6) before and 12 weeks after oral food
Measured: before and 12 weeks after oral food challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study startJun 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Jamer, Wroclaw Medical University
- Investigators
- Tatiana Jamer, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312438
- Sponsor's protocol ID
- OFC2020
- Status last verified
- May 2020
- First submitted
- 8 Mar 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
PubMed 24909706Roberts G. Food challenges, the risks and benefits. Clin Exp Allergy. 2017 Sep;47(9):1106-1107. doi: 10.1111/cea.12999. No abstract available.
PubMed 28856837Beigelman A. To Eat or Not to Eat? Introduction of Food After Negative Oral Food Challenge. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):477-478. doi: 10.1016/j.jaip.2016.09.005. No abstract available.
PubMed 28283161Nowak-Wegrzyn A, Assa'ad AH, Bahna SL, Bock SA, Sicherer SH, Teuber SS; Adverse Reactions to Food Committee of American Academy of Allergy, Asthma & Immunology. Work Group report: oral food challenge testing. J Allergy Clin Immunol. 2009 Jun;123(6 Suppl):S365-83. doi: 10.1016/j.jaci.2009.03.042.
PubMed 19500710Cox AL, Nowak-Wegrzyn A. Innovation in Food Challenge Tests for Food Allergy. Curr Allergy Asthma Rep. 2018 Oct 30;18(12):74. doi: 10.1007/s11882-018-0825-3.
PubMed 30377836Gupta M, Cox A, Nowak-Wegrzyn A, Wang J. Diagnosis of Food Allergy. Immunol Allergy Clin North Am. 2018 Feb;38(1):39-52. doi: 10.1016/j.iac.2017.09.004. Epub 2017 Oct 23.
PubMed 29132673
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy
- ClinicalTrials.gov ID
- NCT04312438
- Acronym / sponsor ID
- OFC2020
- Conditions
- Food Allergy
- Keywords
- oral food challenge, food allergy, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 18 Mar 2020 (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 aim of the study is to assess the safety of an oral food challenge (OFC) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet.
Detailed description
The aim of the study is to assess the safety of an oral food challenge test with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with food allergies after introducing cow's milk into the diet.
The study covers children over 12 months of age diagnosed with cow's milk allergy, treated with a non-dairy elimination diet based on extensively-hydrolyzed formulas or amino acid formulas, admitted to the Department of Pediatrics, Gastroenterology and Nutrition to conduct an open oral food challenge. In all children, after appropriate assessment and qualification (interview, physical examination, skin prick tests, results of allergen - specific immunoglobulin E (IgE), total blood count, fecal calprotectin and lactoferrin), an oral food challenge test with cow's milk will be performed. The oral food challenge test will be carried out in accordance with current standards and with child protection in the event of an adverse reactions. During the food challenge test (first 24 hours), after 2 weeks (phone survey) and 3 months after the test (visit to the Department) the frequency, severity and type of allergic reactions and cow's milk protein tolerance will be assessed. The safety of oral food challenge with cow's milk protein in children previously fed with extensively - hydrolyzed formulas or amino acid formulas will be compared. The results of allergy tests, total blood count and intestinal inflammatory markers (fecal calprotectin and fecal lactoferrin) will also be assessed before and 12 weeks after oral food challenge. The assessment of the incidence and severity of allergic reactions and tolerance of cow's milk proteins after introduction into the diet in children challenged with cow's milk proteins may help to establish guidelines on the qualifications and how to conduct an oral challenge test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 13 mo to 15 yo children diagnosed with Cow's Milk Allergy | Experimental | Diagnostic Test: oral food challenge with cow's milk proteinsoral food challenge with cow's milk proteins |
Who may qualify
- Ages
- 13 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged from 13 months to 15 years
- children diagnosed with cow's milk allergy treated with a dairy-free diet
- informed consent of the child's parents/legal guardians to participate in the study
Key exclusion criteria (5 listed)
- occurrence of anaphylactic reaction after ingestion cow's milk proteins less than 12 months
- positive skin prick test with cow's milk proteins
- milk specific serum IgE values > 17,5 kU/L
- age below 13 moths
- no consent of the child's parents/legal guardians to participate in the study
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 |
|---|---|---|
| oral food challenge with cow's milk proteinsin children with diagnosed Cow's Milk Allergy open oral food challenge test with cow's milk protein (milk formula in children up to 3 yo, cow,s milk after 3 yo) will be carried out | Diagnostic test | 13 mo to 15 yo children diagnosed with Cow's Milk Allergy |
Primary outcome
Incidence of allergic reaction during and after oral food challenge assessed by the occurrence of allergic symptoms in children
Time frame: up to 12 weeks after oral food challenge
assessment of type, severity and frequency of food allergy symptoms (allergic skin changes, gastrointestinal and respiratory tract symptoms) that occurred during and after oral food challenge, based on medical history data and physical examination collected by a doctor
Change of hemoglobin level after 12 weeks after oral food challenge
Time frame: before and 12 weeks after oral food challenge
hemoglobin concentration in venous blood measured in g/dl
Changes in skin prick test results 12 weeks after oral food challenge
Time frame: before and 12 weeks after oral food challenge
skin prick test with milk, egg yolk, egg white, chicken, wheat, fish before and 12 weeks after oral food challenge
Changes in allergen - specific IgE pediatric panel results 12 weeks after oral food challenge
Time frame: before and 12 weeks after oral food challenge
allergen - specific IgE pediatric panel results (allergen - specific IgE concentration measured in kU/l, classified in grades 0-6) before and 12 weeks after oral food challenge
Change of fecal calprotectin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge
Time frame: before and 12 weeks after oral food challenge
concentration of fecal calprotectin in the feces measured in ug/g before and 12 weeks afte oral food challenge
Change of fecal lactoferrin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge
Time frame: before and 12 weeks after oral food challenge
concentration of fecal lactoferrin in the feces measured in μg/g before and 12 weeks afte oral food challenge
3 secondary outcomes
Comparison of the incidence of allergic reaction during and after oral food challenge with cow's milk protein between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
Time frame: up to 12 weeks after oral food challenge
Comparison of changes in skin prick test results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
Time frame: before and 12 weeks after oral food challenge
comparison of changes in allergen - specific IgE pediatric panel results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
Time frame: before and 12 weeks after oral food challenge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Background: PubMed 24909706Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
- Background: PubMed 28856837Roberts G. Food challenges, the risks and benefits. Clin Exp Allergy. 2017 Sep;47(9):1106-1107. doi: 10.1111/cea.12999. No abstract available.
- Background: PubMed 28283161Beigelman A. To Eat or Not to Eat? Introduction of Food After Negative Oral Food Challenge. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):477-478. doi: 10.1016/j.jaip.2016.09.005. No abstract available.
- Background: PubMed 19500710Nowak-Wegrzyn A, Assa'ad AH, Bahna SL, Bock SA, Sicherer SH, Teuber SS; Adverse Reactions to Food Committee of American Academy of Allergy, Asthma & Immunology. Work Group report: oral food challenge testing. J Allergy Clin Immunol. 2009 Jun;123(6 Suppl):S365-83. doi: 10.1016/j.jaci.2009.03.042.
- Background: PubMed 30377836Cox AL, Nowak-Wegrzyn A. Innovation in Food Challenge Tests for Food Allergy. Curr Allergy Asthma Rep. 2018 Oct 30;18(12):74. doi: 10.1007/s11882-018-0825-3.
- Background: PubMed 29132673Gupta M, Cox A, Nowak-Wegrzyn A, Wang J. Diagnosis of Food Allergy. Immunol Allergy Clin North Am. 2018 Feb;38(1):39-52. doi: 10.1016/j.iac.2017.09.004. Epub 2017 Oct 23.
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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.
Tatiana Jamer, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral food challenge with cow's milk proteins in people with Food Allergy, run by Wroclaw Medical University at 1 site in Poland.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 May 2020. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Jamer, PhD (+48 508 124 186, tatiana.jamer@umed.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of allergic reaction during and after oral food challenge assessed by the occurrence of allergic symptoms in children (time frame: up to 12 weeks after oral food challenge). The study lists 6 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 NCT04312438, 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 19 May 2020.