CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
symbiotic +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01899677
NCT01899677Phase 3Completed
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The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants

Zeynep Kamil Maternity and Pediatric Research and Training Hospital·interventional·Posted Jul 15, 2013·Updated Aug 8, 2014

In Brief

A Phase 3 clinical trial evaluating distilled water and symbiotic for Necrotising Enterocolitis. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNecrotising Enterocolitis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 15, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.0 years ago

Interventions

distilled waterother

0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days

symbioticdrug

Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days