NCT01899677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 6, 2014

Completed
Last Updated

August 8, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

July 1, 2013

Results QC Date

July 13, 2014

Last Update Submit

August 5, 2014

Conditions

Necrotising Enterocolitis

Keywords

Symbiotic,cytokines, necrotising enterocolitis

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

symbiotic

EXPERIMENTAL

symbiotic preparation 1/2 sachet twice daily during 30 days

Drug: symbiotic

distilled water

PLACEBO COMPARATOR

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

Other: distilled water

Interventions

distilled waterOTHER

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

distilled water
symbioticDRUG

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

Also known as: Probiotic ATP
symbiotic

Eligibility Criteria

Age1 Hour - 2 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • PROM\> 24 hour and/or chorioamnionitis
  • Mechanical ventilation supply more than 7 days
  • Culture proven sepsis
  • Major congenital anomaly
  • Neonates undergoing surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Child Health Hospital

Istanbul, Umraniye, 34668, Turkey (Türkiye)

Location

Related 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.

    PMID: 18626975BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Ozge Serce (Investigator, MD)
Organization
Zeynep Kamil Maternity and Children's Education Training Hospital
ozge_serce@hotmail.com
+905323270375

Study Officials

  • Fahri Ovali

    Zeynep Kamil Maternity and Childen Education and Training Hospital

    STUDY DIRECTOR

  • Ozge Serce

    Zeynep Kamil Maternity and Childen Education and Training Hospital

    PRINCIPAL INVESTIGATOR

  • Tugba Gursoy, MD

    Zeynep Kamil Maternity and Children Education and Training Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist in neonatology

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 15, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 8, 2014

Results First Posted

August 6, 2014

Record last verified: 2014-08

Locations

TU(1)