Recruitment

Recruitment Status
Completed
Estimated Enrollment
130

Inclusion Criteria

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

Exclusion Criteria

Metabolically unstable patient
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
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

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

Exclusion Criteria

Metabolically unstable patient
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
Patients with severe disease in the last 30 days

Tracking Information

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