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The Efficacy of Symbiotic on Cytokines

Primary Purpose

Necrotising Enterocolitis

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
distilled water
symbiotic
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotising Enterocolitis focused on measuring Symbiotic,cytokines, necrotising enterocolitis

Eligibility Criteria

1 Hour - 2 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zeynep Kamil Maternity and Child Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

symbiotic

distilled water

Arm Description

symbiotic preparation 1/2 sachet twice daily during 30 days

2 x 0.5 cc distilled water will be given during 30 days

Outcomes

Primary Outcome Measures

Interleukin 5 Serum Cytokine Level on 0+2 Day
Interleukin 5 Levels on 14+/-2 Day
Interleukin 5 Levels at 28+/-2 Day
Interleukin 10 Levels at 0+2 Days
Interleukin 10 Levels at 14+/- 2 Days
Interleukin 10 Levels at 28+/-2 Days
Interleukin 17A Levels at 0+2 Days
Interleukin 17A Levels at 14+/- 2 Days
Interleukin 17A Levels at 28+/-2 Days
Interferon Levels at 0+2 Days
Interferon Levels at 14+/-2 Days
Interferon Levels at 28+/-2 Days

Secondary Outcome Measures

Full Information

First Posted
July 1, 2013
Last Updated
August 5, 2014
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01899677
Brief Title
The Efficacy of Symbiotic on Cytokines
Official Title
The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Inclusion criteria: Neonates who born 26- 32 gestational week and 750-1500 gram birth weights Neonates who tolerated minimal enteral feeding within postnatal first week Exclusion criteria: PROM> 24 hours and/or chorioamnionitis Mechanic ventilation supply more than 7 days Culture proven sepsis Major congenital anomaly 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotising Enterocolitis
Keywords
Symbiotic,cytokines, necrotising enterocolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
symbiotic
Arm Type
Experimental
Arm Description
symbiotic preparation 1/2 sachet twice daily during 30 days
Arm Title
distilled water
Arm Type
Placebo Comparator
Arm Description
2 x 0.5 cc distilled water will be given during 30 days
Intervention Type
Other
Intervention Name(s)
distilled water
Intervention Description
0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
Intervention Type
Drug
Intervention Name(s)
symbiotic
Other Intervention Name(s)
Probiotic ATP
Intervention Description
Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
Primary Outcome Measure Information:
Title
Interleukin 5 Serum Cytokine Level on 0+2 Day
Time Frame
0+2 day
Title
Interleukin 5 Levels on 14+/-2 Day
Time Frame
14+/-2 day
Title
Interleukin 5 Levels at 28+/-2 Day
Time Frame
28+/-2 day
Title
Interleukin 10 Levels at 0+2 Days
Time Frame
0+2 days
Title
Interleukin 10 Levels at 14+/- 2 Days
Time Frame
14+/- 2 days
Title
Interleukin 10 Levels at 28+/-2 Days
Time Frame
28+/-2 days
Title
Interleukin 17A Levels at 0+2 Days
Time Frame
0+2 days
Title
Interleukin 17A Levels at 14+/- 2 Days
Time Frame
14+/- 2 days
Title
Interleukin 17A Levels at 28+/-2 Days
Time Frame
28+/-2 days
Title
Interferon Levels at 0+2 Days
Time Frame
0+2 days
Title
Interferon Levels at 14+/-2 Days
Time Frame
14+/-2 days
Title
Interferon Levels at 28+/-2 Days
Time Frame
28+/-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights Neonates who tolerated minimal enteral feeding during first week of life Exclusion Criteria: PROM> 24 hour and/or chorioamnionitis Mechanical ventilation supply more than 7 days Culture proven sepsis Major congenital anomaly Neonates undergoing surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahri Ovali
Organizational Affiliation
Zeynep Kamil Maternity and Childen Education and Training Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ozge Serce
Organizational Affiliation
Zeynep Kamil Maternity and Childen Education and Training Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tugba Gursoy, MD
Organizational Affiliation
Zeynep Kamil Maternity and Children Education and Training Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zeynep Kamil Maternity and Child Health Hospital
City
Istanbul
State/Province
Umraniye
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18626975
Citation
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.
Results Reference
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The Efficacy of Symbiotic on Cytokines

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