infants at high risk of developing allergy
Conditions
Interventions
Active product: Formula /follow-up formula with partially hydrolysed whey
protein supplemented with prebiotics and probiotics (HP synbiotics)
Control product: standard formula/follow-up formula (com
Sponsors
Nutricia
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1) Healthy term infants (gestational age * 37 and * 42 weeks) at high risk of developing allergy based on family history of allergy.;2) Infants aged * 16 weeks (max. 16 weeks + 0 days), preferably as soon as possible after birth.;3) Infants with birth weight within normal range for gestational age and sex (10th to 90th percentile according to local applicable growth charts).;4) Infants who start formula feeding within 16 weeks of age (infants of mothers who have chosen not to breastfeed or mothers who completely/partially cease breastfeeding before the subject*s age of 16 weeks) OR Infants who are exclusively breastfed and whose mothers have the intention to exclusively breastfeed at least until their infant is 16 weeks of age.;5) Written informed consent from one or both parents (according to local laws) and/or legal guardian.
Exclusion criteria
Exclusion criteria: 1) Consumption of any amount of infant formula based on intact protein before randomisation.;2) Consumption of any amount of infant formula with added probiotics and/or probiotic supplement before randomisation.;3) Existing allergic manifestations (e.g. allergic skin disorders, food allergy) before randomisation according to investigator*s clinical assessment.;4) Severe congenital abnormalities which could influence the subjects* growth (e.g. cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, major congenital heart disease, or any other condition according to investigator's clinical judgement).;5) Severe neonatal illnesses (e.g. respiratory distress syndrome, severe sepsis intraventricular hemorrhage, severe neonatal jaundice, necrotizing enterocolitis, persistent pulmonary hypertension of the newborn, or any other condition which required the use of intravenous antibiotic).;6) Known underlying disease predisposing to infection (e.g. HIV, viral hepatitis B, and C, auto-immune diabetes, immune deficiency).;7) Severe renal failure and hepatic failure according to investigator's clinical judgement.;8) Incapability of the parents to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;9) Participation in other studies involving investigational or marketed products concomitantly or within two weeks prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study investigates the effect of HP synbiotics compared to standard infant formula on the development of allergic manifestations up to the age of 12 months in infants at high risk of developing allergy. The primary outcome parameter will be chosen based on the results of an independent study (TEMPO). The choice will be implemented during the interim analysis (see protocol section 10) and documented in an administrative protocol amendment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of HP synbiotics compared to standard infant formula on the development of growth, safety, allergic manifestations (immune and/or microbiota parameters in faeces, blood and saliva) up to the age of 12 months in infants at high risk of developing allergy. | — |
Countries
Netherlands
Outcome results
None listed