Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||13 Months - 15 Years|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Wroclaw Medical University|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
- - hydrolyzed formulas or amino acid formulas will be compared.
Experimental: 13 mo to 15 yo children diagnosed with Cow's Milk Allergy
oral food challenge with cow's milk proteins
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.