The Efficacy of Symbiotic on Cytokines

Necrotising Enterocolitis Clinical Trial

Official title: The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotising Enterocolitis

• NCT number: NCT01899677
• Study type: Interventional
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Completion date: September 2013