NL-OMON50109
Completed
Phase 3
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 sites44 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- infants at high risk of developing allergy
- Sponsor
- utricia
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility 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)
- •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\)
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,
Outcomes
Primary Outcomes
Not specified
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