Atopic Diseases Clinical Trial
Official title:
The Effect of Low Protein, Extensively Hydrolyzed Infant Formula on Allergy Prevention in At-risk Infants up to 1 Year of Age: a Randomized, Double-blind, Controlled Intervention Study and the Long-term Effect on Allergy Prevention of Early Nutrition Given in the First 120 Days of Life in At-risk Infants Until the Child is 6 Years of Age
Verified date | March 2023 |
Source | HiPP GmbH & Co. Vertrieb KG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.
Status | Active, not recruiting |
Enrollment | 1170 |
Est. completion date | March 2026 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 56 Days |
Eligibility | Inclusion Criteria: - Healthy term-born male and female infants (gestational Age =37+0, singleton birth) - Birth weight = 2500 g and = 4500 g - Age at enrollment: = 56 days of life - At risk of developing atopic diseases - Free of atopy symptoms at Screening and at any time before randomization - Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed - Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk): - IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life - breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life. - No other infant formulas or solid foods are allowed. - Written informed consent. Exclusion Criteria: - Multiple births - Premature delivery (gestational age = 36+6) - Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision) - Significant congenital abnormalities - Participation in another clinical study with an IP or study method that would influence the outcome of this study - Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Second specialized obstetric and gynecological hospital for active treatment Sheinovo EAD | Sofia | |
Czechia | Nemocnice Strakonice, a.s. | Strakonice | |
Finland | Suomen Terveystalo Oy | Tampere | |
France | CHU Estaing | Clermont-Ferrand | |
Germany | Charité Universitätsmedizin Berlin | Berlin | |
Germany | Klinik für Kinder- und Jugendmedizin der Ruhruniversität Bochum im St. Josef Hospital | Bochum | |
Germany | Studienambulanz der pädiatrische Pneumologie und AllergologieKlinik für Kinder- und Jugendmedizin (KKJM) | Frankfurt | |
Germany | Klinik für Kinder und Jugendmedizin | Hamm | |
Germany | Klinik für Kinder- und Jugendmedizin Marienhospital gGmbH Wesel | Wesel | |
Italy | Unità Allergologia-Unità Allergologia- | Roma | |
Poland | Instytut Mikroekologii | Poznan | |
Portugal | Hospital braga | Braga | |
Serbia | Clinical Hospital Center "Dr Dragisa Misovic-Dedinje" | Belgrade | |
Spain | Complejo Hospitalario Universitario de Santiago | Santiago De Compostela |
Lead Sponsor | Collaborator |
---|---|
HiPP GmbH & Co. Vertrieb KG |
Bulgaria, Czechia, Finland, France, Germany, Italy, Poland, Portugal, Serbia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative incidence of atopic dermatitis | Presence of atopic dermatitis on physical examination | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00503048 -
Markers of Atopy in Children With Presumed Early Exposure to Allergens, Unhygienic Conditions, and Infections
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N/A |