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

Not Applicable

Completed

• Conditions: Malnutrition; Cystic Fibrosis; Failure to Thrive
• Interventions: Dietary Supplement: Standard Formula; Dietary Supplement: Symbiotic Formula with DHA and antioxidants

• Registration Number: NCT02128984
• Lead Sponsor: Laboratorios Ordesa

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Primary Completion: 2015-02
• Study Completion: 2015-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Formula	Standard Formula	Standard isocaloric and isonitrogenous formula.
Vitafos Junior	Symbiotic Formula with DHA and antioxidants	Symbiotic Formula with DHA and antioxidants

Primary Outcome Measures

Name	Time	Method
Changes in inflammatory response	At 3rd and 6th months	Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Instituto Nacional de Salud del Niño; 🇵🇪 Lima, Breña, Peru

Hospital de Henares; 🇪🇸 Coslada, Madrid, Spain

Hospital Universitario Santa Lucía; 🇪🇸 Cartagena, Murcia, Spain

Hospital Puerta del Mar; 🇪🇸 Cádiz, Spain

Hospital de Torrecárdenas; 🇪🇸 Almería, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain