| Registry | NCT01807858 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: quadruple, prevention |
| Enrollment | 400 (Estimated) |
| Sponsor | Dr. Sami Ulus Children's Hospital (Other) |
| Conditions | Necrotizing Enterocolitis, Sepsis |
| Interventions | Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin, İnulin (Dietary supplement, other) |
| Dates | start 2012-10-01, primary completion 2013-10-01 (estimated), completion 2013-12-01 (estimated), first posted 2013-03-08, last updated 2013-03-08 |
| Locations | 4 sites in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Necrotizing Enterocolitis All trials for Sepsis All trials of Bifidobacterium lactis All trials of Bifidobacterium lactis plus İnülin
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bifidobacterium lactis | Active comparator | Dietary Supplement: Bifidobacterium lactis plus İnülin; Other: Maltodextrin; Dietary Supplement: İnulin | 5 billion Bifidobacterium lactis |
| İnulin | Active comparator | Dietary Supplement: Bifidobacterium lactis; Dietary Supplement: Bifidobacterium lactis plus İnülin; Other: Maltodextrin | 900 mg İnulin per day will be given |
| Maltodextrin | Placebo comparator | Dietary Supplement: Bifidobacterium lactis; Dietary Supplement: Bifidobacterium lactis plus İnülin; Dietary Supplement: İnulin | Maltodextrin |
| Bifidobacterium lactis plus İnülin | Active comparator | Dietary Supplement: Bifidobacterium lactis; Other: Maltodextrin; Dietary Supplement: İnulin | 5 billion active Bifidobacterium lactis plus 900 mg İnülin per day |
Sex: All, ages: any to 30 Days, accepts healthy volunteers
Inclusion Criteria: * VLBW infants admitted to NICU at the first 7 days of life Exclusion Criteria: * expected life lower than 7 days, * babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.), * severe asphyxia, * severe congenital anomaly
| Facility | City | Country | Status |
|---|---|---|---|
| Şevket Yılmaz Research Hospital | Bursa | Turkey (Türkiye) | Recruiting |
| Diyarbakır Research Hospital | Diyarbakır | Turkey (Türkiye) | Recruiting |
| Okmeydani Research Hospital | Istanbul | Turkey (Türkiye) | Recruiting |
| Umraniye Research Hospital | Istanbul | Turkey (Türkiye) | Recruiting |