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Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacterium lactis plus inulin | Active Comparator | Bifidobacterium lactis plus inulin |
|
| maltodextrin | Placebo Comparator | maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium lactis plus inulin | Dietary Supplement | 5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis | 8 weeks |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Banu Aydın, MD | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sami Ulus CH | Ankara | Ankara | 06120 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21468216 | Result | Ellis CL, Rutledge JC, Underwood MA. Intestinal microbiota and blue baby syndrome: probiotic therapy for term neonates with cyanotic congenital heart disease. Gut Microbes. 2010 Nov-Dec;1(6):359-66. doi: 10.4161/gmic.1.6.14077. | |
| 24043284 | Derived | Dilli D, Aydin B, Zenciroglu A, Ozyazici E, Beken S, Okumus N. Treatment outcomes of infants with cyanotic congenital heart disease treated with synbiotics. Pediatrics. 2013 Oct;132(4):e932-8. doi: 10.1542/peds.2013-1262. Epub 2013 Sep 16. |
| Label | URL |
|---|---|
| http://www.ncbi.nlm.nih.gov/pubmed/21468216 | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 12, 2013 | |
| Reset | Aug 23, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2013 | Aug 23, 2013 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Maltodextrin | Dietary Supplement | same amount of maltodextrin per day will be given as placebo |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |