A randomised, double-blind, controlled, parallel-group, multi-country study to investigate the effect of a partially hydrolysed infant formula with added synbiotics on the development of allergic manifestations in infants at high risk of developing allergy. - MAESTRO study

utricia0 个研究点目标入组 212 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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)
•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.

•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.

发起方

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