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The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

D

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

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

Trial contacts and locations

4

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Central trial contact

Dilek Dilli, Assoc Prof

Data sourced from clinicaltrials.gov

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