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NCT02128984 Clinical Trial

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

Cystic Fibrosis Clinical Trial

— VITJUNIOR  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02128984
Other study ID # VIT-2572-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date May 2015

Study information
Verified date July 2019
Source Laboratorios Ordesa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Symbiotic Formula with DHA and antioxidants
6 months intervention.
• Standard Formula
6 months intervention.

Locations
Country Name City State
Peru Instituto Nacional de Salud del Niño Lima Breña
Spain Hospital de Torrecárdenas Almería
Spain Hospital Puerta del Mar Cádiz
Spain Hospital Universitario Santa Lucía Cartagena Murcia
Spain Hospital de Henares Coslada Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Virgen Macarena Sevilla
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (3)
Lead Sponsor Collaborator
Laboratorios Ordesa Peruvian Clinical Research, Quantum Experimental

Countries where clinical trial is conducted

Peru,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Other Tolerability of the formula Tolerability to the formula in both groups At 1st, 3rd and 6th months
Primary Changes in inflammatory response Differences in faecal calprotectin's levels after 3rd and 6th months of treatment. At 3rd and 6th months
Secondary 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
Secondary Changes in microbiota profile Differences measured by changes in faecal microbiota composition. At 3rd and 6th months
Secondary Changes in Interleukin levels Differences in faecal interleukin levels. Only for cystic fibrosis patients. At 6th month
Secondary Incidence of Infections Episodes of infections during the study period At 1st, 3rd and 6th months
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