NL-OMON50109已完成3 期
A randomised, double-blind, controlled, parallel-group, multi-country study to investigate the effect of a partially hydrolysed infant formula with added synbiotics on gut microbiota composition and clinical effectiveness in infants at high risk of developing allergy. - TEMPO study
utricia0 个研究点目标入组 44 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •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.
排除标准
- •1) Consumption of any amount of infant formula based on intact protein before
- •randomization, except from consumption during the first 72 hours of life., 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 and/or intrmuscular
- •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.
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