Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections

Study Overview
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Brief Summary
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In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF

Detailed Description
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In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included <2mo of age.

Official Title
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A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants

Conditions
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Growth, Infections

Intervention / Treatment
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* Other: cows milk infant formula and follow-on formula with bioactive ingredients
* Other: standard cows milk infant formula and follow-on formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term infants Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g Boys and girls Apparently healthy at birth and screening Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards Age at enrolment: ≤60 days of age If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion If 1 month < age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2 Being available for follow up until the age of 12 months Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years Exclusion Criteria: Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID)) Incapability of parents to comply with the study protocol Illiterate parents (i.e. not able to read and write in local language) Participation in another clinical trial Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 60 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test formula<br>infant formula and follow-on formula with bioactive ingredients | Other: cows milk infant formula and follow-on formula with bioactive ingredients<br>* infant formula and follow-on formula with bioactive ingredients<br>|
| Active Comparator: control formula<br>standard infant formula and follow-on formula | Other: standard cows milk infant formula and follow-on formula<br>* standard cows milk infant formula and follow-on formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | weight for age, compared to WHO growth curve, for test group only | until age of 6 months | 
| infection-related morbidity episodes, parent-reported | number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group | 6 - 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | weight for age, compared to WHO growth curve, for control group | until the age of 6 months | 
| length | length in cm | until the age of 6 months | 
| head circumference | head circumference in cm | until the age of 6 months | 
| BMI | BMI in kg/m2 | until the age of 6 months | 
| product tolerance: GI comfort | GI comfort questionnaire | until the age of 6 months | 
| product tolerance: stool frequency and consistency | stool frequency and consistency questionnaire | until the age of 6 months | 
| product tolerance: product intake | product intake (ml/feeding, ml/day) | until the age of 6 months | 
| Duration of infection-related episodes | duration of parental-reported respiratory and gut infection-related symptoms in summed days | 6 - 12 months of age | 
| infection-related morbidity episodes, physician-diagnosed | number of physician-diagnosed respiratory and gut infection-related symptoms | 6 - 12 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant nutrition, growth, gut comfort, product tolerance, infections