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

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 Overview

• Status: Completed
• Conditions: Necrotising Enterocolitis
• Intervention / Treatment: Drug: symbiotic; Other: distilled water

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Umraniye
    • Istanbul, Umraniye, Turkey, 34668
      • Zeynep Kamil Maternity and Child Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Symbiotic,cytokines, necrotising enterocolitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: 14893