The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum, Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing enterocolitis pathogenesis in very low birth weight neonates.
Inclusion criteria: 1. Neonates who born 26- 32 gestational week and 750-1500 gram birth weights 2. Neonates who tolerated minimal enteral feeding within postnatal first week Exclusion criteria: 1. PROM\> 24 hours and/or chorioamnionitis 2. Mechanic ventilation supply more than 7 days 3. Culture proven sepsis 4. Major congenital anomaly 5. Patients undergoing surgery Intervention: The allocations will contain in opaque, sequentially numbered sealed envelopes. The study group will receive symbiotic preparation (Probiotic ATP, Nobel, 1/2 sachet twice daily); whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily) which will be added to breast milk or formula starting with the first feed.0.5 cc blood sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. This samples will turn by cold centrifugation and store at -20 °C temperature. The cytokines will be analysed by ELISA multiplex method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
Zeynep Kamil Maternity and Child Health Hospital
Istanbul, Umraniye, Turkey (Türkiye)
Interleukin 5 Serum Cytokine Level on 0+2 Day
Time frame: 0+2 day
Interleukin 5 Levels on 14+/-2 Day
Time frame: 14+/-2 day
Interleukin 5 Levels at 28+/-2 Day
Time frame: 28+/-2 day
Interleukin 10 Levels at 0+2 Days
Time frame: 0+2 days
Interleukin 10 Levels at 14+/- 2 Days
Time frame: 14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days
Time frame: 28+/-2 days
Interleukin 17A Levels at 0+2 Days
Time frame: 0+2 days
Interleukin 17A Levels at 14+/- 2 Days
Time frame: 14+/- 2 days
Interleukin 17A Levels at 28+/-2 Days
Time frame: 28+/-2 days
Interferon Levels at 0+2 Days
Time frame: 0+2 days
Interferon Levels at 14+/-2 Days
Time frame: 14+/-2 days
Interferon Levels at 28+/-2 Days
Time frame: 28+/-2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.