Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.

Detailed Description
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An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial. The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.

Official Title
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Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life

Conditions
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Infections, Stool Flora, Stool Biochemistry, Constipation, Food Intolerance

Intervention / Treatment
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* Dietary Supplement: new infant formula with prebiotics and beta-palmitate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy term neonates gestational age 37 to 42 weeks birth weight 10th to 90th percentile (Voigt reference) infants being exclusively formula-fed at enrollment Exclusion Criteria: infants with high risk of atopic disease due to family history congenital disorder or syndrome with need for special diet / impairment of growth antibiotic medication prior to enrollment

Ages Eligible for Study
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Maximum Age: 10 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Formula<br>Standard formula with no supplementation | |
| Experimental: experimental formula<br>infant formula with higher beta-palmitate and supplemented GOS | Dietary Supplement: new infant formula with prebiotics and beta-palmitate<br>* experimental infant formula as sole source of nutrition over first 12 weeks of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of gastrointestinal infections |  | within first year of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of bifidobacteria on total stool bacteria |  | after 6 and 12 weeks intervention | 
| number of infectious episodes (gastrointestinal, respiratory, fever episodes) |  | within first year of life | 
| anthropometric parameters (gain in weight, length, head circumference) |  | after 6 weeks, after 12 weeks intervention | 
| symptoms of food intolerance, constipation, colics | number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation | after 6 weeks, 12 weeks intervention | 
| stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools) |  | after 6 weeks, 12 weeks intervention | 
| atopic manifestation | incidence atopic dermatitis | within 1st year of life | 
| erythrocytes´ fatty acid profile | palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane) | after 6 weeks intervention | 
| calcium absorption | urinary calcium-creatinin ratio, serum alkaline phosphatase | after 6 weeks, 12 weeks intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, prebiotics, beta-palmitate, stool flora, bifidogenic