Clinical Trial: The Efficacy of Symbiotic on Cytokines

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Targeted cytokine blood levels via symbiotics [ Time Frame: 3 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Dates:
Date Received: July 1, 2013
Date Started: July 2013
Date Completion:
Last Updated: August 5, 2014
Last Verified: August 2014