The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Dr. Sami Ulus Children's Hospital

Status: Unknown

Conditions: Necrotizing Enterocolitis; Sepsis

Treatments: Dietary Supplement: Bifidobacterium lactis; Dietary Supplement: Bifidobacterium lactis plus İnülin; Dietary Supplement: İnulin; Other: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT01807858

68/16.Oct.2012

Details and patient eligibility

About

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.

Full description

Patients separated into four groups using the sealed envelope method.

Enrollment: 400 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups, including a placebo group

Bifidobacterium lactis

Active Comparator group

Description:

5 billion Bifidobacterium lactis

Treatment:

Dietary Supplement: İnulin

Dietary Supplement: Bifidobacterium lactis plus İnülin

Other: Maltodextrin

İnulin

Active Comparator group

Description:

900 mg İnulin per day will be given

Treatment:

Dietary Supplement: Bifidobacterium lactis

Dietary Supplement: Bifidobacterium lactis plus İnülin

Other: Maltodextrin

Maltodextrin

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Bifidobacterium lactis

Dietary Supplement: İnulin

Dietary Supplement: Bifidobacterium lactis plus İnülin

Bifidobacterium lactis plus İnülin

Active Comparator group

Description:

5 billion active Bifidobacterium lactis plus 900 mg İnülin per day

Treatment:

Dietary Supplement: Bifidobacterium lactis

Dietary Supplement: İnulin

Other: Maltodextrin