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|
- - age 1-12 months
- IgE-mediated CMA
Exclusion Criteria:- cow's milk protein-induced anaphylaxis, - food protein induced enterocolitis syndrome, - other food allergies, - other allergic diseases, - non-CMA-related atopic eczema, - eosinophilic disorders of the gastrointestinal tract, - chronic systemic diseases, - congenital cardiac defects, - active tuberculosis, - autoimmune diseases, - immunodeficiency, - chronic inflammatory bowel diseases, - celiac disease, - cystic fibrosis, - metabolic diseases, - malignancy, - chronic pulmonary diseases, - malformations of the gastrointestinal and/or respiratory tract, - administration of prebiotics or probiotics during the 4 weeks before enrolment.
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.
|Federico II University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Allergy Milk, Allergy;Food, Allergic Asthma, Allergic Conjunctivitis, Allergy Skin|
: extensively hydrolyzed casein formula+LGG
subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG as exclusion diet
: extensively hydrolyzed whey formula;
subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed whey formula as exclusion diet
: hydrolyzed rice formula
subjects with IgE mediated cow milk allergy treated with hydrolyzed rice formula as exclusion diet
: soy based formula
subjects with IgE mediated cow milk allergy treated with soy based formula as exclusion diet
: amino-acid based formula
subjects with IgE mediated cow milk allergy treated with amino-acid based formula as exclusion diet
Dietary Supplement: - hypoallergenic formulas
hypoallergenic formulas used for cow milk allergy treatment
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.
University of Naples Federico II
Naples, , 80131