The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Not Applicable

• Conditions: Necrotizing Enterocolitis; Sepsis
• Interventions: Dietary Supplement: Bifidobacterium lactis; Dietary Supplement: Bifidobacterium lactis plus İnülin; Other: Maltodextrin; Dietary Supplement: İnulin

• Registration Number: NCT01807858
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief Summary

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.

Detailed Description

Patients separated into four groups using the sealed envelope method.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-24
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-07
• Last Update Submitted: 2013-03-07
• Study First Posted: 2013-03-08
• Last Update Posted: 2013-03-08
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bifidobacterium lactis	İnulin	5 billion Bifidobacterium lactis
İnulin	Bifidobacterium lactis	900 mg İnulin per day will be given
Bifidobacterium lactis	Bifidobacterium lactis plus İnülin	5 billion Bifidobacterium lactis
Bifidobacterium lactis	Maltodextrin	5 billion Bifidobacterium lactis
İnulin	Bifidobacterium lactis plus İnülin	900 mg İnulin per day will be given
İnulin	Maltodextrin	900 mg İnulin per day will be given
Maltodextrin	Bifidobacterium lactis	Maltodextrin
Maltodextrin	Bifidobacterium lactis plus İnülin	Maltodextrin
Maltodextrin	İnulin	Maltodextrin
Bifidobacterium lactis plus İnülin	Bifidobacterium lactis	5 billion active Bifidobacterium lactis plus 900 mg İnülin per day
Bifidobacterium lactis plus İnülin	Maltodextrin	5 billion active Bifidobacterium lactis plus 900 mg İnülin per day
Bifidobacterium lactis plus İnülin	İnulin	5 billion active Bifidobacterium lactis plus 900 mg İnülin per day

Primary Outcome Measures

Name	Time	Method
Necrotizing enterocolitis	8 weeks	Developing of \>= grade 2 necrotizing enterocolitis suggested by radiological investigation

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	16 weeks	length of hospital stay

Trial Locations

Locations (4)

Okmeydani Research Hospital; 🇹🇷 İstanbul, Turkey

Umraniye Research Hospital; 🇹🇷 İstanbul, Turkey

Şevket Yılmaz Research Hospital; 🇹🇷 Bursa, Turkey

Diyarbakır Research Hospital; 🇹🇷 Diyarbakır, Turkey