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Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.
Patients separated into four groups using the sealed envelope method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacterium lactis | Active Comparator | 5 billion Bifidobacterium lactis |
|
| İnulin | Active Comparator | 900 mg İnulin per day will be given |
|
| Maltodextrin | Placebo Comparator | Maltodextrin |
|
| Bifidobacterium lactis plus İnülin | Active Comparator | 5 billion active Bifidobacterium lactis plus 900 mg İnülin per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium lactis | Dietary Supplement | 5 billion active Bifidobacterium lactis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis | Developing of >= grade 2 necrotizing enterocolitis suggested by radiological investigation | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay | length of hospital stay | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dilek Dilli, Assoc Prof | Contact | 00903123055000 |
| Name | Affiliation | Role |
|---|---|---|
| Dilek Dilli, MD | Assoc Prof | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Şevket Yılmaz Research Hospital | Recruiting | Bursa | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22572829 | Background | Fouhy F, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. Composition of the early intestinal microbiota: knowledge, knowledge gaps and the use of high-throughput sequencing to address these gaps. Gut Microbes. 2012 May-Jun;3(3):203-20. doi: 10.4161/gmic.20169. Epub 2012 May 1. | |
| 25596096 | Derived | Dilli D, Aydin B, Fettah ND, Ozyazici E, Beken S, Zenciroglu A, Okumus N, Ozyurt BM, Ipek MS, Akdag A, Turan O, Bozdag S. The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants. J Pediatr. 2015 Mar;166(3):545-51.e1. doi: 10.1016/j.jpeds.2014.12.004. Epub 2015 Jan 13. |
| Label | URL |
|---|---|
| Are Probiotics Safe For Newborns? \| LIVESTRONG.COM | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 1, 2014 | |
| Reset | Aug 19, 2014 | |
| Release | Aug 20, 2014 | |
| Reset | Aug 31, 2014 | |
| Release | Feb 19, 2015 | |
| Reset | Mar 4, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 1, 2014 | Aug 19, 2014 | |||
| Aug 20, 2014 |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Bifidobacterium lactis plus İnülin | Dietary Supplement | 5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given |
|
|
| Maltodextrin | Other | Maltodextrin |
|
| İnulin | Dietary Supplement | 900 mg inulin per day will be given |
|
| Diyarbakır Research Hospital | Recruiting | Diyarbakır | Turkey (Türkiye) |
|
| Okmeydani Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Umraniye Research Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Aug 31, 2014 |
| Feb 19, 2015 | Mar 4, 2015 |
| D007410 |
| Intestinal Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |