Loading clinical trials...
Loading clinical trials...
The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Zeynep Kamil Maternity and Child Health Hospital
Istanbul, Umraniye, Turkey (Türkiye)
Start Date
July 1, 2013
Primary Completion Date
September 1, 2013
Completion Date
September 1, 2013
Last Updated
August 8, 2014
70
ACTUAL participants
distilled water
OTHER
symbiotic
DRUG
Lead Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01287507