The Efficacy of Symbiotic on Cytokines

Phase 3

Completed

• Conditions: Necrotising Enterocolitis
• Interventions: Drug: symbiotic; Other: distilled water

• Registration Number: NCT01899677
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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 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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Results First Submitted: 2014-07-13
• Results First Submitted QC: 2014-07-13
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Results First Posted: 2014-08-06
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
symbiotic	symbiotic	symbiotic preparation 1/2 sachet twice daily during 30 days
distilled water	distilled water	2 x 0.5 cc distilled water will be given during 30 days

Primary Outcome Measures

Name	Time	Method
Interleukin 10 Levels at 0+2 Days	0+2 days
Interleukin 5 Levels on 14+/-2 Day	14+/-2 day
Interleukin 5 Levels at 28+/-2 Day	28+/-2 day
Interleukin 10 Levels at 14+/- 2 Days	14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days	28+/-2 days
Interleukin 5 Serum Cytokine Level on 0+2 Day	0+2 day
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

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Child Health Hospital; 🇹🇷 Istanbul, Umraniye, Turkey