Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 130
Inclusion Criteria
- 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)
- 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).
- Inform consent signed (parent/legal representative)
- No antibiotherapy in the last 30 days
- Age >= 1 year.
- Stable patients
Exclusion Criteria
- Patients with metabolic intolerance to carbohydrates
- Patients with severe disease in the last 30 days
- Metabolically unstable patient
- ...
- Patients with metabolic intolerance to carbohydrates
- Patients with severe disease in the last 30 days
- 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 Criteria
- 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)
- 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).
- Inform consent signed (parent/legal representative)
- No antibiotherapy in the last 30 days
- Age >= 1 year.
- Stable patients
Exclusion Criteria
- Patients with metabolic intolerance to carbohydrates
- Patients with severe disease in the last 30 days
- Metabolically unstable patient
- ...
- Patients with metabolic intolerance to carbohydrates
- Patients with severe disease in the last 30 days
- Metabolically unstable patient
- Patients with allergy / intolerance to cow's milk proteins
Tracking Information
- NCT #
- NCT02128984
- Collaborators
- Quantum Experimental
- Peruvian Clinical Research
- Investigators
- Not Provided
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