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The Efficacy of Symbiotic on Cytokines

NCT01899677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-08-08

Study results available
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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.

Conditions

  • Necrotising Enterocolitis

Interventions

OTHER

distilled water

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

DRUG

symbiotic

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

Sponsors & Collaborators

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
2 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899677 on ClinicalTrials.gov