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.

Phase 3

Conditions: infants at high risk of developing allergy
10001708

Registration Number: NL-OMON47293

Lead Sponsor: utricia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 212

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study investigates the effect of HP synbiotics compared to standard infant<br /><br>formula on the development of allergic manifestations up to the age of 12<br /><br>months in infants at high risk of developing allergy.<br /><br>The primary outcome parameter will be chosen based on the results of an<br /><br>independent study (TEMPO). The choice will be implemented during the interim<br /><br>analysis (see protocol section 10) and documented in an administrative protocol<br /><br>amendment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the effect of HP synbiotics compared to standard infant formula<br /><br>on the development of growth, safety, allergic manifestations (immune and/or<br /><br>microbiota parameters in faeces, blood and saliva) up to the age of 12 months<br /><br>in infants at high risk of developing allergy.</p><br>