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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 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.
The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saccharomyces boulardii | Experimental | Saccharomyces boulardii 5 million unit/day for 3 months |
|
| control | Placebo Comparator | Placebo- for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardii | Drug | 5 million units/day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Saccharomyces boulardii on culture proved sepsis | 6 months | |
| Effect of Saccharomyces boulardii on weight gain | up to 6 months | |
| Effect of Saccharomyces boulardii on length of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gamze Demirel, MD | Contact | +903123065270 | kgamze@hotmail.com | |
| Ugur Dilmen | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Gamze Demirel, MD | Zekai Tahir Burak Women's Health Research and Education Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak Maternity Teaching Hospital | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37493095 | Derived | Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6. | |
| 33058137 | Derived | Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5. |
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| Placebo | Drug | Placebo for 3 months |
|
| up to 6 months |
| Effect of Saccharomyces boulardii on mortality | 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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