Skip to main content
OpenTrials
Completed

NCT Number: NCT02128984

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Failure to Thrive Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Salud del Niño, Lima, Breña, Peru

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symbiotic Formula with DHA and antioxidants

Dietary Supplement

6 months intervention.

Other names: Vitafos Junior

Standard formula

Dietary Supplement

6 months intervention.

Primary outcomes

  1. Changes in inflammatory response

    Time frame: At 3rd and 6th months

    Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.

Secondary outcomes

  1. Changes in nutritional status

    Time frame: At 3rd and 6th months

    Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.

  2. Changes in microbiota profile

    Time frame: At 3rd and 6th months

    Differences measured by changes in faecal microbiota composition.

  3. Changes in Interleukin levels

    Time frame: At 6th month

    Differences in faecal interleukin levels. Only for cystic fibrosis patients.

  4. Incidence of Infections

    Time frame: At 1st, 3rd and 6th months

    Episodes of infections during the study period

Other outcomes

  1. Tolerability of the formula

    Time frame: At 1st, 3rd and 6th months

    Tolerability to the formula in both groups

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Collaborators

  • Peruvian Clinical Research
  • Quantum Experimental

Registry information

Acronym: VITJUNIOR

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 1, 2014
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.