Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
NCT ID: NCT02351531
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
New Thickened Extensively Hydrolyzed formula
Extensively Hydrolyzed formula
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extensively Hydrolyzed formula
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
* whose parent(s) signed the informed consent form
Exclusion Criteria
* Infants having a weight at inclusion \< 2500g,
* Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
* Infants fed an amino acid based formula
* Infants who had an anaphylactic reaction in the past,
1 Month
12 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Régional
Namur, , Belgium
Necker Children's Hospital
Paris, , France
University of Naples Federico II
Naples, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dupont C, Bradatan E, Soulaines P, Nocerino R, Berni-Canani R. Tolerance and growth in children with cow's milk allergy fed a thickened extensively hydrolyzed casein-based formula. BMC Pediatr. 2016 Jul 18;16:96. doi: 10.1186/s12887-016-0637-3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UP-2013-02
Identifier Type: -
Identifier Source: org_study_id