The Efficacy of Symbiotic on Cytokines

Necrotising Enterocolitis Clinical Trial

Official title:

The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899677
• Other study ID #: 14893
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2013
• Last updated: August 5, 2014
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotising Enterocolitis

Intervention

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

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Maternity and Child Health Hospital	Istanbul	Umraniye

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin 5 Serum Cytokine Level on 0+2 Day		0+2 day	No
Primary	Interleukin 5 Levels on 14+/-2 Day		14+/-2 day	No
Primary	Interleukin 5 Levels at 28+/-2 Day		28+/-2 day	No
Primary	Interleukin 10 Levels at 0+2 Days		0+2 days	No
Primary	Interleukin 10 Levels at 14+/- 2 Days		14+/- 2 days	No
Primary	Interleukin 10 Levels at 28+/-2 Days		28+/-2 days	No
Primary	Interleukin 17A Levels at 0+2 Days		0+2 days	No
Primary	Interleukin 17A Levels at 14+/- 2 Days		14+/- 2 days	No
Primary	Interleukin 17A Levels at 28+/-2 Days		28+/-2 days	No
Primary	Interferon Levels at 0+2 Days		0+2 days	No
Primary	Interferon Levels at 14+/-2 Days		14+/-2 days	No
Primary	Interferon Levels at 28+/-2 Days		28+/-2 days	No