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Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection 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 |
|
| Nystatin | Active Comparator | 50000 unit/3 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Dietary Supplement | Lactobacillus reuteri 100 million CFU/day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants | Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Lactobacillus reuteri on feeding intolerance | Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools) | up to 6 months |
| Effect of Lactobacillus reuteri on sepsis |
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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, Division of Neonatology | Ankara | 06110 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25245226 | Derived | Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9. |
| Label | URL |
|---|---|
| Lactobacillus reuteri | View source |
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| Nystatin | Drug | 50000 unit/3 times a day, both for orally and by orogastric route |
|
|
Patients with culture positivity will accept as proven sepsis. |
| up to 6 months |
| Effect of Lactobacillus reuteri on length of hospital stay | Specified length of hospital stay as days. | up to 6 months |
| 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 |
| Nystatin | View source |
| ID | Term |
|---|---|
| D009761 | Nystatin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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