To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

Study Overview
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Brief Summary
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This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits. Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age. Safety, growth and tolerance parameters will be followed and collected throughout the study.

Official Title
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A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants

Conditions
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Healthy Infants

Intervention / Treatment
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* Dietary Supplement: New infant formula with synbiotics
* Dietary Supplement: Standard infant formula with prebiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Chinese term infants ≤ 44 days Birth weight within normal range Head circumference within normal range Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age Exclusion Criteria: - The mothers of infants: who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation; known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement; - Parents/Legally acceptable representatives/Caregivers of infants: who are incapable to comply with study protocol - Infants: who have to be fed with a special diet other than standard cow's milk based infant formula; known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters known or suspected to have an allergic condition towards cow's milk, soy or fish; with any history of, or current participation in any other study involving investigational or marketed products.

Ages Eligible for Study
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Maximum Age: 44 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group: New infant formula with synbiotics; Control group: Standard infant formula with prebiotics
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New infant formula with synbiotics<br>pHP infant formula with synbiotics (test product) | Dietary Supplement: New infant formula with synbiotics<br>* Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.<br>|
| Active Comparator: Standard infant formula with prebiotics<br>Standard (commercial) infant formula with prebiotics (control product) | Dietary Supplement: Standard infant formula with prebiotics<br>* Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.<br>|
| No Intervention: human milk<br>Full breastfeeding for at least 17 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain per day from baseline (g/day) |  | at the age of 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant. |  | at the age of 17 weeks | 
| Increment per day from baseline on length (mm/day) |  | at the age of 17 weeks | 
| Increment per day from baseline on head circumference (mm/day) |  | at the age of 17 weeks | 
| Increment per day from baseline on mid-upper arm circumference (mm/day) |  | at the age of 17 weeks | 
| Z-scores of anthropometric parameters from baseline on weight |  | from baseline until the age of 17 weeks | 
| Z-scores of anthropometric parameters from baseline on length |  | from baseline until the age of 17 weeks | 
| Z-scores of anthropometric parameters from baseline on head circumference |  | from baseline until the age of 17 weeks | 
| Z-scores of anthropometric parameters from baseline on mid-upper arm circumference |  | from baseline until the age of 17 weeks | 
| Effect on incidence, frequency and severity of (serious) adverse events |  | from baseline until the age of 17 weeks | 
| Parent-reported occurrence of diarrhea |  | from baseline until the age of 17 weeks | 
| Parent-reported severity of diarrhea |  | from baseline until the age of 17 weeks | 
| Parent-reported occurrence of constipation |  | from baseline until the age of 17 weeks | 
| Parent-reported severity of constipation |  | from baseline until the age of 17 weeks |