Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Supplemented Formula · 1 trial · 1 indication
Cumulative incidence of atopic dermatitis at 36 and 48 weeks
| Arm | Type | Description |
|---|---|---|
| Breast Milk | NO_INTERVENTION | Breast FED newborns |
| Standard Formula | PLACEBO_COMPARATOR | Standard Formula FED newborns |
| Supplemented Formula | ACTIVE_COMPARATOR | GOS/PDX Formula FED newborns |
| Name | Type | Description |
|---|---|---|
| Supplemented Formula | DIETARY_SUPPLEMENT | 50:50 mixture of GOS/PDX formula will be administered |
Inclusion Criteria: 1. Gestational age \>37 and \< 42 weeks. 2. Birth weight \> 2500 gr. 3. At risk of atopy (see appendix 1). 4. Informed consent signed by the parents (see appendix 3). Exclusion Criteria: 1. Congenital immunodeficiency 2. Severe congenital disorders or malformations 3. Born to ...
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Supplemented Formula is an investigational product being studied for the prevention of atopic dermatitis in infants. It was evaluated in a Phase 3 clinical trial in Italy with 380 participants, where it was tested against a placebo to assess its effect on reducing the risk of developing this skin condition.
Supplemented Formula is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The company conducted a Phase 3 clinical trial of this product for atopic dermatitis prevention.
Supplemented Formula is in Phase 3 clinical development. A Phase 3 trial, NCT02116452, has been completed, which studied the product in 380 participants for the prevention of atopic dermatitis. The product is investigational and not yet approved for use.
Supplemented Formula has one completed clinical trial, NCT02116452, titled 'Prebiotics in Prevention of Atopy'. This Phase 3, randomized, double-blind, placebo-controlled study enrolled 380 participants with atopic dermatitis in Italy, with participants as young as 1 week old.
Supplemented Formula is not FDA approved. It is an investigational product that has completed a Phase 3 clinical trial for atopic dermatitis prevention, but approval status has not been established. The product remains in clinical development.