Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.

Detailed Description
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This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.

Official Title
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Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children

Conditions
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Cystic Fibrosis, Failure to Thrive, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Symbiotic Formula with DHA and antioxidants
* Dietary Supplement: Standard Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis). Age >= 1 year. Stable patients No antibiotherapy in the last 30 days Inform consent signed (parent/legal representative) Exclusion Criteria: Patients with allergy / intolerance to cow's milk proteins Metabolically unstable patient Patients with metabolic intolerance to carbohydrates Patients with severe disease in the last 30 days

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitafos Junior<br>Symbiotic Formula with DHA and antioxidants | Dietary Supplement: Symbiotic Formula with DHA and antioxidants<br>* 6 months intervention.<br>* Other names: Vitafos Junior;|
| Active Comparator: Standard Formula<br>Standard isocaloric and isonitrogenous formula. | Dietary Supplement: Standard Formula<br>* 6 months intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in inflammatory response | Differences in faecal calprotectin's levels after 3rd and 6th months of treatment. | At 3rd and 6th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutritional status | Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass. | At 3rd and 6th months | 
| Changes in microbiota profile | Differences measured by changes in faecal microbiota composition. | At 3rd and 6th months | 
| Changes in Interleukin levels | Differences in faecal interleukin levels. Only for cystic fibrosis patients. | At 6th month | 
| Incidence of Infections | Episodes of infections during the study period | At 1st, 3rd and 6th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Dietary supplement, Nutritional supplement, Symbiotic formula, DHA, Cystic Fibrosis, Failure to Thrive