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Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri | Experimental | Lactobacillus reuteri 100 million CFU/day for 3 months |
|
| Control | Placebo Comparator | Placebo for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Drug | Lactobacillus reuteri 100 million CFU/day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants | NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Lactobacillus reuteri on culture proved sepsis | Patients with culture positivity will accept as proven sepsis. | up to 6 months |
| Effect of Lactobacillus reuteri on weight gain | The infants will be weight daily on scales that will calibrated weekly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Yekta Oncel, MD | Neonatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit | Ankara | Turkey | 06110 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24309022 | Derived | Oncel MY, Sari FN, Arayici S, Guzoglu N, Erdeve O, Uras N, Oguz SS, Dilmen U. Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F110-5. doi: 10.1136/archdischild-2013-304745. Epub 2013 Dec 5. |
| Label | URL |
|---|---|
| Lactobacillus reuteri | View source |
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| Placebo | Drug | Placebo for 3 months |
|
| up to 6 months |
| Effect of Lactobacillus reuteri on length of hospital stay | Specified length of hospital stay as days | up to 6 months |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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