Recruitment

Recruitment Status
Completed
Estimated Enrollment
130

Inclusion Criterias

Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
Inform consent signed (parent/legal representative)
Age >= 1 year.
...
Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
Inform consent signed (parent/legal representative)
Age >= 1 year.
No antibiotherapy in the last 30 days
Stable patients

Exclusion Criterias

Patients with severe disease in the last 30 days
Patients with metabolic intolerance to carbohydrates
Metabolically unstable patient
...
Patients with severe disease in the last 30 days
Patients with metabolic intolerance to carbohydrates
Metabolically unstable patient
Patients with allergy / intolerance to cow's milk proteins

Summary

Conditions
  • Cystic Fibrosis
  • Failure to Thrive
  • Malnutrition
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 125 years
Gender
Both males and females

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 an...

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.

Inclusion Criterias

Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
Inform consent signed (parent/legal representative)
Age >= 1 year.
...
Malnutrition (P / T <-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
Inform consent signed (parent/legal representative)
Age >= 1 year.
No antibiotherapy in the last 30 days
Stable patients

Exclusion Criterias

Patients with severe disease in the last 30 days
Patients with metabolic intolerance to carbohydrates
Metabolically unstable patient
...
Patients with severe disease in the last 30 days
Patients with metabolic intolerance to carbohydrates
Metabolically unstable patient
Patients with allergy / intolerance to cow's milk proteins

Locations

Cartagena, Murcia, 30202
Zaragoza, 50009
Almería, 04009
Coslada, Madrid, 28822
Cádiz, 11009
...
Cartagena, Murcia, 30202
Zaragoza, 50009
Almería, 04009
Coslada, Madrid, 28822
Cádiz, 11009
Sevilla, 41009
Madrid, 28046
Lima, Breña

Tracking Information

NCT #
NCT02128984
Collaborators
  • Quantum Experimental
  • Peruvian Clinical Research
Investigators
Not Provided