Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	13 Months - 15 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04312438
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Wroclaw Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tatiana Jamer, PhD
Principal Investigator Affiliation	Wroclaw Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

Experimental: 13 mo to 15 yo children diagnosed with Cow's Milk Allergy

oral food challenge with cow's milk proteins

Interventions

Diagnostic Test: - oral food challenge with cow's milk proteins

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Wroclaw Medical University, Wrocław, Poland

Status

Recruiting

Address

Wroclaw Medical University

Wrocław, , 50-367

Site Contact

Tatiana Jamer, PhD

tatiana.jamer@umed.wroc.pl

+48 508 124 186

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