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The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Milk" containing B. Lactis | Experimental | "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. |
|
| "Milk" containing placebo | Placebo Comparator | "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic supplementation | Dietary Supplement | one capsule containing probiotics per day added to milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| NEC onset | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic administration and stool microbiology | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A. Cooper, MD | University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Witwatersrand & Chris Hani Baragwanath Hospital | Bertsham | 2013 | South Africa | |||
| University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital |
| 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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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Milk containing placebo | Dietary Supplement | one capsule containing placebo per day added to milk |
|
| Johannesburg |
| 2000 |
| South Africa |
| University of Witwatersrand & Rahima Moosa Mother & Child Hospital | Johannesburg | 2112 | South Africa |
| D007410 |
| Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |