Cystic Fibrosis, Failure to Thrive, Malnutrition
Conditions
Keywords
Malnutrition, Dietary supplement, Nutritional supplement, Symbiotic formula, DHA, Cystic Fibrosis, Failure to Thrive
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.
Interventions
DIETARY_SUPPLEMENTSymbiotic Formula with DHA and antioxidants
6 months intervention.
DIETARY_SUPPLEMENTStandard Formula
6 months intervention.
Sponsors
Quantum Experimental
Peruvian Clinical Research
Laboratorios Ordesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in inflammatory response | At 3rd and 6th months | Differences in faecal calprotectin's levels after 3rd and 6th months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in nutritional status | At 3rd and 6th months | Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass. |
| Changes in microbiota profile | At 3rd and 6th months | Differences measured by changes in faecal microbiota composition. |
| Changes in Interleukin levels | At 6th month | Differences in faecal interleukin levels. Only for cystic fibrosis patients. |
| Incidence of Infections | At 1st, 3rd and 6th months | Episodes of infections during the study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the formula | At 1st, 3rd and 6th months | Tolerability to the formula in both groups |
Countries
Peru, Spain
Outcome results
None listed