Effect of an Infant Formula on Infant Growth, Health and Immune Functions

Study Overview
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Brief Summary
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The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.

Detailed Description
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Breast-fed infants will be used as a reference group and formula-fed infants will be fed control formula or the same formula supplemented with Osteopontin at a concentration 50% or 100% of that of breast milk. The hypothesis is that supplementation of bovine milk Osteopontin in infant formula will have positive effects on infant growth, health and immune functions.

Official Title
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Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial

Conditions
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Health, Growth, Immune Functions

Intervention / Treatment
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* Other: Infant formula supplemented with bovine milk Osteopontin
* Other: Standard infant formula


Participation Criteria
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Eligibility Criteria
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Mothers Inclusion Criteria: Healthy, 19-40 years of age Plan to exclusively breast-fed or formula-fed Infants Exclusion Criteria: Gestational age < 37 or > 42 weeks Birth weight < 2.5kg or > 4 kg Having congenital diseases Having birth Asphyxia Having birth infections

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Reference group<br>Human milk breastfeeding | |
| Active Comparator: Control formula<br>Standard infant formula, with no Osteopontin supplemented. | Other: Standard infant formula<br>* Infant formula without supplementation of bovine milk Osteopontin<br>* Other names: Lactopontin;|
| Active Comparator: Formula with 50% Osteopontin<br>Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk. | Other: Infant formula supplemented with bovine milk Osteopontin<br>* Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.<br>* Other names: Lactopontin;|
| Active Comparator: Formula with 100% Osteopontin<br>Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk. | Other: Infant formula supplemented with bovine milk Osteopontin<br>* Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.<br>* Other names: Lactopontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions. |  | 1, 4, and 6 postnatal months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric parameters: body length, body weight, and head circumferences at each visit. |  | 1, 2, 3, 4, 5, and 6 postnatal months | 
| Dietary, stool consistency and well being recorded by 3 day questionnaires |  | 1, 2, 3, 4, 5, and 6 postnatal months | 
| Adverse events and concomitant medications recorded by heath forms as a measure of safety and tolerability. |  | 1, 2, 3, 4, 5, and 6 postnatal months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant formula, Bovine milk Osteopontin, growth, health, immune functions