Title
The Efficacy of Symbiotic on Cytokines
The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
Phase
Phase 3Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Necrotising EnterocolitisIntervention/Treatment
water ...Study Participants
70The 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:
Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
Neonates who tolerated minimal enteral feeding within postnatal first week
Exclusion criteria:
PROM> 24 hours and/or chorioamnionitis
Mechanic ventilation supply more than 7 days
Culture proven sepsis
Major congenital anomaly
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.
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
2 x 0.5 cc distilled water will be given during 30 days
Inclusion Criteria: Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights Neonates who tolerated minimal enteral feeding during first week of life Exclusion Criteria: PROM> 24 hour and/or chorioamnionitis Mechanical ventilation supply more than 7 days Culture proven sepsis Major congenital anomaly Neonates undergoing surgery
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