NCT01899677|CompletedPhase 3ResultsDMC
The Efficacy of Symbiotic on Cytokines
The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
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Sponsor study identifier
interventional
70
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 1, 2013
Actual (reported)July 15, 2013
Actual (reported)September 2013
Actual (reported)September 2013
Actual (reported)August 6, 2014
Actual (reported)Interleukin 5 Serum Cytokine Level on 0+2 Day
0+2 day
Interleukin 5 Levels on 14+/-2 Day
14+/-2 day
Interleukin 5 Levels at 28+/-2 Day
28+/-2 day
Interleukin 10 Levels at 0+2 Days
0+2 days
Interleukin 10 Levels at 14+/- 2 Days
14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days
28+/-2 days
Interleukin 17A Levels at 0+2 Days
symbiotic preparation 1/2 sachet twice daily during 30 days
2 x 0.5 cc distilled water will be given during 30 days
0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
Zeynep Kamil Maternity and Child Health Hospital
Istanbul, Umraniye, 34668, Turkey (Türkiye)
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.
Fahri Ovali
Zeynep Kamil Maternity and Childen Education and Training Hospital
Ozge Serce
Zeynep Kamil Maternity and Childen Education and Training Hospital
Tugba Gursoy, MD
Zeynep Kamil Maternity and Children Education and Training Hospital
70 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2013
First Posted
July 15, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
August 8, 2014
Results First Posted
August 6, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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