Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02116452 | Prebiotics in Prevention of Atopy | PHASE3 | COMPLETED | 380 | — | — | Nov 1, 2011 | - | Apr 16, 2014 | 1 | Italy |
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 ...