The Efficacy of Symbiotic on Cytokines

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.

Timeline

Start

2013-07

Primary completion

2013-09

Completion

2013-09

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Symbiotic vs Distilled Water; p = 0.32; Mann whitney U NCT01899677 ↗

registry analysis (superiority or other test); Symbiotic vs Distilled Water; p = 0.73; Mann whitney U NCT01899677 ↗

registry analysis (superiority or other test); Symbiotic vs Distilled Water; p = 0.66; Mann whitney U NCT01899677 ↗

registry analysis (superiority or other test); Symbiotic vs Distilled Water; p = 0.76; Mann whitney U NCT01899677 ↗

Publications

• Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Symbiotic	Unknown	0.5 unknown	—

Indications