NL-OMON34471
Completed
Phase 2
An exploratory study to evaluate the effect of a new study product on early programming in healthy infants - EAGLE2
Danone Vitapole0 sites28 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- healthy subjects
- Sponsor
- Danone Vitapole
- Enrollment
- 28
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy and full\-term infants (gestational age \* 37 and \* 42 weeks)
- •Birth weight within the normal range for gestational age and sex (10th to 90th percentiles according to applicable growth charts)
- •Age \* 7 weeks at screening
- •Body weight appropriate for the individual age and sex at screening (10th to 90th percentiles according to applicable growth charts)
- •Infants who are fully formula fed or have started the transition from breast\- to formula\-feeding (indicated by the feeding of at least one bottle of infant formula in the past) and are planning to stop breastfeeding voluntarily by infant\*s age of 7 weeks
- •Written informed consent of both parent(s)/legal guardian(s)
Exclusion Criteria
- •Infants not on full formula feeding at the age of 7 weeks (to be answered latest at the age of 8 weeks (visit 2\))
- •Infants with known congenital diseases or malfunctions e.g. gastrointestinal malformations, haemophilia
- •Current or previous illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation)
- •\*Infants with abnormal growth (too slow (\< \-1SD) or too fast (\> \+1SD) weight gain) within the 10th to 90th percentiles of applicable weight\-for\-age charts for either boys or girls
- •Infants at high risk to develop an atopic disease (at least one parent or sibling with manifest atopic symptoms of hay fever, asthma or atopic dermatitis)
- •Infants needing a special diet other than standard cow\*s milk\-based infant milk formula
- •\*Infants whose mothers are known to suffer from hepatitis B, human immunodeficiency virus (HIV), high blood\-pressure, hyperlipidaemia or diabetes
- •Infants whose mother was overweight (BMI \* 27\) prior to pregnancy
- •Infants with any historical or current participation in any other study involving investigational or marketed products
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements and instructions
Outcomes
Primary Outcomes
Not specified
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