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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
6 months intervention.
6 months intervention.
Instituto Nacional de Salud del Niño
Lima, Breña, Peru
Hospital de Henares
Coslada, Madrid, Spain
Hospital Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital de Torrecárdenas
Almería, Spain
Changes in inflammatory response
Differences in faecal calprotectin's levels after 3rd and 6th months of treatment.
Time frame: At 3rd and 6th months
Changes in nutritional status
Differences measured by changes in weight, height, growth Z-scores, fat body mass and lean body mass.
Time frame: At 3rd and 6th months
Changes in microbiota profile
Differences measured by changes in faecal microbiota composition.
Time frame: At 3rd and 6th months
Changes in Interleukin levels
Differences in faecal interleukin levels. Only for cystic fibrosis patients.
Time frame: At 6th month
Incidence of Infections
Episodes of infections during the study period
Time frame: At 1st, 3rd and 6th months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Puerta del Mar
Cadiz, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain