Clinical Study With an Enteral Formula With Symbiotic and... | NCT02128984

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

NCT02128984

Sponsor

Laboratorios Ordesa

Status

Completed

Last Update Posted

Jul 19, 2019Actual

Enrollment

109Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis
Failure to Thrive
Malnutrition

Interventions

Symbiotic Formula with DHA and antioxidants
Standard Formula

Countries

Peru
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Feb 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Mar 28, 2014

First Submission Date that Met QC Criteria

Apr 30, 2014

First Posted Date

May 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2019

Last Update Posted Date

Jul 19, 2019Actual

Name	Class
Quantum Experimental	UNKNOWN
Peruvian Clinical Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitafos Junior	Experimental	Symbiotic Formula with DHA and antioxidants	Dietary Supplement: Symbiotic Formula with DHA and antioxidants
Standard Formula	Active Comparator	Standard isocaloric and isonitrogenous formula.	Dietary Supplement: Standard Formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Symbiotic Formula with DHA and antioxidants	Dietary Supplement	6 months intervention.	Vitafos Junior

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
Changes in microbiota profile	Differences measured by changes in faecal microbiota composition.

Other Outcomes

Measure	Description	Time Frame
Tolerability of the formula	Tolerability to the formula in both groups	At 1st, 3rd and 6th months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Salud del Niño		Lima	Breña		Peru
Hospital de Henares

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis
D005183	Failure to Thrive
D044342	Malnutrition

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000975	Antioxidants

Ancestor Terms

ID	Term
D001685	Biological Factors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided