The Efficacy of Symbiotic on Cytokines

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Necrotising Enterocolitis

Intervention / Treatment
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* Other: distilled water
* Drug: symbiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: symbiotic<br>symbiotic preparation 1/2 sachet twice daily during 30 days | Drug: symbiotic<br>* Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days<br>* Other names: Probiotic ATP;|
| Placebo Comparator: distilled water<br>2 x 0.5 cc distilled water will be given during 30 days | Other: distilled water<br>* 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 5 Serum Cytokine Level on 0+2 Day |  | 0+2 day | 
| Interleukin 5 Levels on 14+/-2 Day |  | 14+/-2 day | 
| Interleukin 5 Levels at 28+/-2 Day |  | 28+/-2 day | 
| Interleukin 10 Levels at 0+2 Days |  | 0+2 days | 
| Interleukin 10 Levels at 14+/- 2 Days |  | 14+/- 2 days | 
| Interleukin 10 Levels at 28+/-2 Days |  | 28+/-2 days | 
| Interleukin 17A Levels at 0+2 Days |  | 0+2 days | 
| Interleukin 17A Levels at 14+/- 2 Days |  | 14+/- 2 days | 
| Interleukin 17A Levels at 28+/-2 Days |  | 28+/-2 days | 
| Interferon Levels at 0+2 Days |  | 0+2 days | 
| Interferon Levels at 14+/-2 Days |  | 14+/-2 days | 
| Interferon Levels at 28+/-2 Days |  | 28+/-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symbiotic,cytokines, necrotising enterocolitis