Phase 3
N=70
The Efficacy of Symbiotic on Cytokines
Necrotising Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT01899677 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Interleukin 5 Serum Cytokine Level on 0+2 Day — 4; 4 pg/ml — p=0.32
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- distilled water (Other); symbiotic (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interleukin 5 Serum Cytokine Level on 0+2 Day |
4; 4 | 0.32 |
| PRIMARY Interleukin 5 Levels on 14+/-2 Day |
4; 4 | 0.73 |
| PRIMARY Interleukin 5 Levels at 28+/-2 Day |
3; 3 | 0.66 |
| PRIMARY Interleukin 10 Levels at 0+2 Days |
13; 10 | 0.76 |
| PRIMARY Interleukin 10 Levels at 14+/- 2 Days |
12; 16 | — |
| PRIMARY Interleukin 10 Levels at 28+/-2 Days |
10; 11 | — |
| PRIMARY Interleukin 17A Levels at 0+2 Days |
1; 1 | — |
| PRIMARY Interleukin 17A Levels at 14+/- 2 Days |
1; 1 | — |
| PRIMARY Interleukin 17A Levels at 28+/-2 Days |
1; 1 | — |
| PRIMARY Interferon Levels at 0+2 Days |
6; 6.5 | — |
| PRIMARY Interferon Levels at 14+/-2 Days |
8; 7.5 | — |
| PRIMARY Interferon Levels at 28+/-2 Days |
9; 7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01899677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.