Clinical trial NCT01899677: The Efficacy of Symbiotic on Cytokines
Official title: The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Necrotising Enterocolitis
Keywords: Symbiotic,cytokines, necrotising enterocolitis
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin 5 Serum Cytokine Level on 0+2 Day
timeFrame: 0+2 day
measure: Interleukin 5 Levels on 14+/-2 Day
timeFrame: 14+/-2 day
measure: Interleukin 5 Levels at 28+/-2 Day
timeFrame: 28+/-2 day
measure: Interleukin 10 Levels at 0+2 Days
timeFrame: 0+2 days
measure: Interleukin 10 Levels at 14+/- 2 Days
timeFrame: 14+/- 2 days
measure: Interleukin 10 Levels at 28+/-2 Days
timeFrame: 28+/-2 days
measure: Interleukin 17A Levels at 0+2 Days
timeFrame: 0+2 days
measure: Interleukin 17A Levels at 14+/- 2 Days
timeFrame: 14+/- 2 days
measure: Interleukin 17A Levels at 28+/-2 Days
timeFrame: 28+/-2 days
measure: Interferon Levels at 0+2 Days
timeFrame: 0+2 days
measure: Interferon Levels at 14+/-2 Days
timeFrame: 14+/-2 days
measure: Interferon Levels at 28+/-2 Days
timeFrame: 28+/-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Child Health Hospital
state: Umraniye
Study officials:
affiliation: Zeynep Kamil Maternity and Childen Education and Training Hospital
name: Fahri Ovali
role: STUDY_DIRECTOR
affiliation: Zeynep Kamil Maternity and Childen Education and Training Hospital
name: Ozge Serce
role: PRINCIPAL_INVESTIGATOR
affiliation: Zeynep Kamil Maternity and Children Education and Training Hospital
name: Tugba Gursoy, MD
role: STUDY_CHAIR
References:
citation: Ng SC, Hart AL, Kamm MA, Stagg AJ, Knight SC. Mechanisms of action of probiotics: recent advances. Inflamm Bowel Dis. 2009 Feb;15(2):300-10. doi: 10.1002/ibd.20602.