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Completed

NCT Number: NCT01899677

The Efficacy of Symbiotic on Cytokines

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.

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Key information

Conditions

Necrotising Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

1 hour–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zeynep Kamil Maternity and Child Health Hospital

Istanbul, Umraniye, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distilled water

Other

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

symbiotic

Drug

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

Other names: Probiotic ATP

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2013
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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