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The Efficacy of Symbiotic on Cytokines

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ClinicalTrials.gov Identifier: NCT01899677
Recruitment Status : Completed
First Posted : July 15, 2013
Results First Posted : August 6, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ozge Serce, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Necrotising Enterocolitis Other: distilled water Drug: symbiotic Phase 3

Detailed Description:

Inclusion criteria:

  1. Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
  2. Neonates who tolerated minimal enteral feeding within postnatal first week

Exclusion criteria:

  1. PROM> 24 hours and/or chorioamnionitis
  2. Mechanic ventilation supply more than 7 days
  3. Culture proven sepsis
  4. Major congenital anomaly
  5. Patients undergoing surgery

Intervention:

The allocations will contain in opaque, sequentially numbered sealed envelopes. The study group will receive symbiotic preparation (Probiotic ATP, Nobel, 1/2 sachet twice daily); whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily) which will be added to breast milk or formula starting with the first feed.0.5 cc blood sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. This samples will turn by cold centrifugation and store at -20 °C temperature. The cytokines will be analysed by ELISA multiplex method.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
Study Start Date : July 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: symbiotic
symbiotic preparation 1/2 sachet twice daily during 30 days
 Drug: symbiotic
Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
Other Name: Probiotic ATP
Placebo Comparator: distilled water
2 x 0.5 cc distilled water will be given during 30 days
 Other: distilled water
0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days


Outcome Measures
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Primary Outcome Measures :
  1. Interleukin 5 Serum Cytokine Level on 0+2 Day [ Time Frame: 0+2 day ]
  2. Interleukin 5 Levels on 14+/-2 Day [ Time Frame: 14+/-2 day ]
  3. Interleukin 5 Levels at 28+/-2 Day [ Time Frame: 28+/-2 day ]
  4. Interleukin 10 Levels at 0+2 Days [ Time Frame: 0+2 days ]
  5. Interleukin 10 Levels at 14+/- 2 Days [ Time Frame: 14+/- 2 days ]
  6. Interleukin 10 Levels at 28+/-2 Days [ Time Frame: 28+/-2 days ]
  7. Interleukin 17A Levels at 0+2 Days [ Time Frame: 0+2 days ]
  8. Interleukin 17A Levels at 14+/- 2 Days [ Time Frame: 14+/- 2 days ]
  9. Interleukin 17A Levels at 28+/-2 Days [ Time Frame: 28+/-2 days ]
  10. Interferon Levels at 0+2 Days [ Time Frame: 0+2 days ]
  11. Interferon Levels at 14+/-2 Days [ Time Frame: 14+/-2 days ]
  12. Interferon Levels at 28+/-2 Days [ Time Frame: 28+/-2 days ]

Eligibility Criteria
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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
  2. Neonates who tolerated minimal enteral feeding during first week of life

Exclusion Criteria:

  1. PROM> 24 hour and/or chorioamnionitis
  2. Mechanical ventilation supply more than 7 days
  3. Culture proven sepsis
  4. Major congenital anomaly
  5. Neonates undergoing surgery
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899677


Locations
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Turkey
Zeynep Kamil Maternity and Child Health Hospital
Istanbul, Umraniye, Turkey, 34668
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Investigators
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Study Director: Fahri Ovali Zeynep Kamil Maternity and Childen Education and Training Hospital
Principal Investigator: Ozge Serce Zeynep Kamil Maternity and Childen Education and Training Hospital
Study Chair: Tugba Gursoy, MD Zeynep Kamil Maternity and Children Education and Training Hospital
More Information
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Publications:

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Responsible Party: Ozge Serce, specialist in neonatology, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01899677    
Other Study ID Numbers: 14893
First Posted: July 15, 2013    Key Record Dates
Results First Posted: August 6, 2014
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Ozge Serce, Zeynep Kamil Maternity and Pediatric Research and Training Hospital:
Symbiotic,cytokines, necrotising enterocolitis
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases