The Efficacy of Symbiotic on Cytokines

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

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.

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Detailed Description

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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.

Conditions

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Necrotising Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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symbiotic

symbiotic preparation 1/2 sachet twice daily during 30 days

Group Type EXPERIMENTAL

symbiotic

Intervention Type DRUG

Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days

distilled water

2 x 0.5 cc distilled water will be given during 30 days

Group Type PLACEBO_COMPARATOR

distilled water

Intervention Type OTHER

0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days

Interventions

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distilled water

0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days

Intervention Type OTHER

symbiotic

Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days

Intervention Type DRUG

Other Intervention Names

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Probiotic ATP

Eligibility Criteria

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Inclusion Criteria

1. Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
2. Neonates who tolerated minimal enteral feeding during first week of life

Exclusion Criteria

1. PROM\> 24 hour and/or chorioamnionitis
2. Mechanical ventilation supply more than 7 days
3. Culture proven sepsis
4. Major congenital anomaly
5. Neonates undergoing surgery

Minimum Eligible Age

1 Hour

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes