Recruitment

Recruitment Status
Completed
Estimated Enrollment
130

Inclusion Criteria

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

Exclusion Criteria

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

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 Criteria

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

Exclusion Criteria

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

Locations

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

Tracking Information

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