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.

Phase 3

Completed

• Conditions: infants at high risk of developing allergy; 10001708

• Registration Number: NL-OMON50109
• Lead Sponsor: utricia

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-01-21
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

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
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified