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||1 Month - 12 Months|
- - Babies of both sexes.
- - Age < 12 months.
- - Clinical history of immediate reaction (<2 hours) after the intake of baby's formula and/or foods containing cow's milk.
- - Sensitization to cow's milk proteins demonstrated by: - sIgE to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein >0.1KU/l (ImmunoCAP®, ThemoFisher) and/or - Skin prick test to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein ≥3mm - If the reaction to milk occurred over 3 months before the recruitment, it will be mandatory to confirm reactivity to milk with an oral food test.
- - Parents / legal representatives of the participant voluntary accept to participate.
- - Delayed reactions (> 2 h) after milk intake.
- - Contact urticaria to milk if ingestion is well tolerated.
- - Previous participation in oral tolerance induction/desensitization protocols.
- - Treatment with any medication that might interfere the evaluation of the primary outcome or any study procedure.
- - Any disease or condition which presents a contraindication to perform an oral challenge, either open or double-blind or any other study procedure.
- - Social circumstances that might interfere with protocol adherence.
- - Egg and/or wheat allergy (this exclusion criterion shall be verified before the beginning of the intervention).
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.
|Hospital San Carlos, Madrid|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Inmaculada Cerecedo, e: MD, PhD|
|Principal Investigator Affiliation||Hospital Clinico San Carlos|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|IgE-mediated Milk Allergy|
Experimental: Dietary intervention
Meals containing Milk and Milk
No Intervention: Historical cohort
Other: - Milk
Meals containing Milk and Milk
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.