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

Primary Purpose

Cystic Fibrosis, Failure to Thrive, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Symbiotic Formula with DHA and antioxidants
Standard Formula
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Malnutrition, Dietary supplement, Nutritional supplement, Symbiotic formula, DHA, Cystic Fibrosis, Failure to Thrive

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Salud del Niño
  • Hospital de Henares
  • Hospital Universitario Santa Lucía
  • Hospital de Torrecárdenas
  • Hospital Puerta del Mar
  • Hospital Universitario La Paz
  • Hospital Virgen Macarena
  • Hospital Universitario Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitafos Junior

Standard Formula

Arm Description

Symbiotic Formula with DHA and antioxidants

Standard isocaloric and isonitrogenous formula.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in nutritional status
Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.
Changes in microbiota profile
Differences measured by changes in faecal microbiota composition.
Changes in Interleukin levels
Differences in faecal interleukin levels. Only for cystic fibrosis patients.
Incidence of Infections
Episodes of infections during the study period

Full Information

First Posted
March 28, 2014
Last Updated
July 17, 2019
Sponsor
Laboratorios Ordesa
Collaborators
Quantum Experimental, Peruvian Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02128984
Brief Title
Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
Acronym
VITJUNIOR
Official Title
Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
Collaborators
Quantum Experimental, Peruvian Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Failure to Thrive, Malnutrition
Keywords
Malnutrition, Dietary supplement, Nutritional supplement, Symbiotic formula, DHA, Cystic Fibrosis, Failure to Thrive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitafos Junior
Arm Type
Experimental
Arm Description
Symbiotic Formula with DHA and antioxidants
Arm Title
Standard Formula
Arm Type
Active Comparator
Arm Description
Standard isocaloric and isonitrogenous formula.
Intervention Type
Dietary Supplement
Intervention Name(s)
Symbiotic Formula with DHA and antioxidants
Other Intervention Name(s)
Vitafos Junior
Intervention Description
6 months intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Formula
Intervention Description
6 months intervention.
Primary Outcome Measure Information:
Title
Changes in inflammatory response
Description
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
Time Frame
At 3rd and 6th months
Secondary Outcome Measure Information:
Title
Changes in nutritional status
Description
Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.
Time Frame
At 3rd and 6th months
Title
Changes in microbiota profile
Description
Differences measured by changes in faecal microbiota composition.
Time Frame
At 3rd and 6th months
Title
Changes in Interleukin levels
Description
Differences in faecal interleukin levels. Only for cystic fibrosis patients.
Time Frame
At 6th month
Title
Incidence of Infections
Description
Episodes of infections during the study period
Time Frame
At 1st, 3rd and 6th months
Other Pre-specified Outcome Measures:
Title
Tolerability of the formula
Description
Tolerability to the formula in both groups
Time Frame
At 1st, 3rd and 6th months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Nacional de Salud del Niño
City
Lima
State/Province
Breña
Country
Peru
Facility Name
Hospital de Henares
City
Coslada
State/Province
Madrid
ZIP/Postal Code
28822
Country
Spain
Facility Name
Hospital Universitario Santa Lucía
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30202
Country
Spain
Facility Name
Hospital de Torrecárdenas
City
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://congresoaep2015.pulsointeractivo.com/readcontents.php?file=webstructure/04_comunic.orales-def.pdf
Description
Spanish Pediatric Association (AEP) Congress 2015 - Oral Comunications Book - CO48
URL
http://congresoaep2015.pulsointeractivo.com/readcontents.php?file=webstructure/05_pos.moderados-def.pdf
Description
Spanish Pediatric Association (AEP) Congress 2015 - Posters Book - P101

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

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