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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.
Inclusion criteria:
Exclusion criteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symbiotic | Experimental | symbiotic preparation 1/2 sachet twice daily during 30 days |
|
| distilled water | Placebo Comparator | 2 x 0.5 cc distilled water will be given during 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| distilled water | Other | 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Kamil Maternity and Child Health Hospital | Istanbul | Umraniye | 34668 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18626975 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Very low birth weight neonates
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Distilled Water |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interleukin 5 Serum Cytokine Level on 0+2 Day | Posted | Median | Inter-Quartile Range | pg/ml | 0+2 day |
|
|
during trial (0-3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ozge Serce (Investigator, MD) | Zeynep Kamil Maternity and Children's Education Training Hospital | +905323270375 | ozge_serce@hotmail.com |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| symbiotic | Drug | Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days |
|
|
| 28+/-2 days |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| birth weight | Mean | Standard Deviation | grams |
|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Interleukin 5 Levels on 14+/-2 Day | Posted | Median | Inter-Quartile Range | pg/ml | 14+/-2 day |
|
|
|
|
| Primary | Interleukin 5 Levels at 28+/-2 Day | Posted | Mean | Inter-Quartile Range | pg/ml | 28+/-2 day |
|
|
|
|
| Primary | Interleukin 10 Levels at 0+2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 0+2 days |
|
|
|
|
| Primary | Interleukin 10 Levels at 14+/- 2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 14+/- 2 days |
|
|
|
| Primary | Interleukin 10 Levels at 28+/-2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 28+/-2 days |
|
|
|
| Primary | Interleukin 17A Levels at 0+2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 0+2 days |
|
|
|
| Primary | Interleukin 17A Levels at 14+/- 2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 14+/- 2 days |
|
|
|
| Primary | Interleukin 17A Levels at 28+/-2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 28+/-2 days |
|
|
|
| Primary | Interferon Levels at 0+2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 0+2 days |
|
|
|
| Primary | Interferon Levels at 14+/-2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 14+/-2 days |
|
|
|
| Primary | Interferon Levels at 28+/-2 Days | Posted | Median | Inter-Quartile Range | pg/ml | 28+/-2 days |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 28 | 0 | 28 |
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| D007410 |
| Intestinal Diseases |