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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01899677
Enrollment
70
Registered
2013-07-15
Start date
2013-07-31
Completion date
2013-09-30
Last updated
2014-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotising Enterocolitis

Keywords

Symbiotic,cytokines, necrotising enterocolitis

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: 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.

Interventions

OTHERdistilled water

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

DRUGsymbiotic

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

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Interleukin 5 Serum Cytokine Level on 0+2 Day0+2 day
Interleukin 5 Levels on 14+/-2 Day14+/-2 day
Interleukin 5 Levels at 28+/-2 Day28+/-2 day
Interleukin 10 Levels at 0+2 Days0+2 days
Interleukin 10 Levels at 14+/- 2 Days14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days28+/-2 days
Interleukin 17A Levels at 0+2 Days0+2 days
Interleukin 17A Levels at 14+/- 2 Days14+/- 2 days
Interleukin 17A Levels at 28+/-2 Days28+/-2 days
Interferon Levels at 0+2 Days0+2 days
Interferon Levels at 14+/-2 Days14+/-2 days
Interferon Levels at 28+/-2 Days28+/-2 days

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Symbiotic
symbiotic preparation 1/2 sachet twice daily during 30 days symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
25
Distilled Water
2 x 0.5 cc distilled water will be given during 30 days distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
28
Total53

Baseline characteristics

CharacteristicSymbioticDistilled WaterTotal
Age, Categorical
<=18 years
25 Participants28 Participants53 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
birth weight1266 grams
STANDARD_DEVIATION 228
1230 grams
STANDARD_DEVIATION 262
1245 grams
STANDARD_DEVIATION 247
Sex: Female, Male
Female
13 Participants10 Participants23 Participants
Sex: Female, Male
Male
12 Participants18 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 250 / 28
serious
Total, serious adverse events
0 / 250 / 28

Outcome results

Primary

Interferon Levels at 0+2 Days

Time frame: 0+2 days

ArmMeasureValue (MEDIAN)
SymbioticInterferon Levels at 0+2 Days6 pg/ml
Distilled WaterInterferon Levels at 0+2 Days6.5 pg/ml
Primary

Interferon Levels at 14+/-2 Days

Time frame: 14+/-2 days

ArmMeasureValue (MEDIAN)
SymbioticInterferon Levels at 14+/-2 Days8 pg/ml
Distilled WaterInterferon Levels at 14+/-2 Days7.5 pg/ml
Primary

Interferon Levels at 28+/-2 Days

Time frame: 28+/-2 days

ArmMeasureValue (MEDIAN)
SymbioticInterferon Levels at 28+/-2 Days9 pg/ml
Distilled WaterInterferon Levels at 28+/-2 Days7 pg/ml
Primary

Interleukin 10 Levels at 0+2 Days

Time frame: 0+2 days

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 10 Levels at 0+2 Days13 pg/ml
Distilled WaterInterleukin 10 Levels at 0+2 Days10 pg/ml
p-value: 0.76Mann whitney U
Primary

Interleukin 10 Levels at 14+/- 2 Days

Time frame: 14+/- 2 days

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 10 Levels at 14+/- 2 Days12 pg/ml
Distilled WaterInterleukin 10 Levels at 14+/- 2 Days16 pg/ml
Primary

Interleukin 10 Levels at 28+/-2 Days

Time frame: 28+/-2 days

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 10 Levels at 28+/-2 Days10 pg/ml
Distilled WaterInterleukin 10 Levels at 28+/-2 Days11 pg/ml
Primary

Interleukin 17A Levels at 0+2 Days

Time frame: 0+2 days

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 17A Levels at 0+2 Days1 pg/ml
Distilled WaterInterleukin 17A Levels at 0+2 Days1 pg/ml
Primary

Interleukin 17A Levels at 14+/- 2 Days

Time frame: 14+/- 2 days

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 17A Levels at 14+/- 2 Days1 pg/ml
Distilled WaterInterleukin 17A Levels at 14+/- 2 Days1 pg/ml
Primary

Interleukin 17A Levels at 28+/-2 Days

Time frame: 28+/-2 days

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 17A Levels at 28+/-2 Days1 pg/ml
Distilled WaterInterleukin 17A Levels at 28+/-2 Days1 pg/ml
Primary

Interleukin 5 Levels at 28+/-2 Day

Time frame: 28+/-2 day

ArmMeasureValue (MEAN)
SymbioticInterleukin 5 Levels at 28+/-2 Day3 pg/ml
Distilled WaterInterleukin 5 Levels at 28+/-2 Day3 pg/ml
p-value: 0.66Mann whitney U
Primary

Interleukin 5 Levels on 14+/-2 Day

Time frame: 14+/-2 day

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 5 Levels on 14+/-2 Day4 pg/ml
Distilled WaterInterleukin 5 Levels on 14+/-2 Day4 pg/ml
p-value: 0.73Mann whitney U
Primary

Interleukin 5 Serum Cytokine Level on 0+2 Day

Time frame: 0+2 day

ArmMeasureValue (MEDIAN)
SymbioticInterleukin 5 Serum Cytokine Level on 0+2 Day4 pg/ml
Distilled WaterInterleukin 5 Serum Cytokine Level on 0+2 Day4 pg/ml
Comparison: Mann Whitney U test was used to compare cytokine levels between groups.p-value: 0.32Mann whitney U

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026