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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-05-31

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.

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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.

Conditions

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Cystic Fibrosis Failure to Thrive Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitafos Junior

Symbiotic Formula with DHA and antioxidants

Group Type EXPERIMENTAL

Symbiotic Formula with DHA and antioxidants

Intervention Type DIETARY_SUPPLEMENT

6 months intervention.

Standard Formula

Standard isocaloric and isonitrogenous formula.

Group Type ACTIVE_COMPARATOR

Standard Formula

Intervention Type DIETARY_SUPPLEMENT

6 months intervention.

Interventions

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Symbiotic Formula with DHA and antioxidants

6 months intervention.

Intervention Type DIETARY_SUPPLEMENT

Standard Formula

6 months intervention.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitafos Junior

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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No