NCT01807858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

December 24, 2012

Last Update Submit

March 7, 2013

Conditions

Necrotizing EnterocolitisSepsis

Keywords

Necrotizing enterocolitisSepsisLength of hospital stayMortality

Outcome Measures

Primary Outcomes (1)

  • Necrotizing enterocolitis

    Developing of \>= grade 2 necrotizing enterocolitis suggested by radiological investigation

    8 weeks

Secondary Outcomes (1)

  • length of hospital stay

    16 weeks

Study Arms (4)

Bifidobacterium lactis

ACTIVE COMPARATOR

5 billion Bifidobacterium lactis

Dietary Supplement: Bifidobacterium lactis plus İnülinOther: MaltodextrinDietary Supplement: İnulin

İnulin

ACTIVE COMPARATOR

900 mg İnulin per day will be given

Dietary Supplement: Bifidobacterium lactisDietary Supplement: Bifidobacterium lactis plus İnülinOther: Maltodextrin

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Bifidobacterium lactisDietary Supplement: Bifidobacterium lactis plus İnülinDietary Supplement: İnulin

Bifidobacterium lactis plus İnülin

ACTIVE COMPARATOR

5 billion active Bifidobacterium lactis plus 900 mg İnülin per day

Dietary Supplement: Bifidobacterium lactisOther: MaltodextrinDietary Supplement: İnulin

Interventions

Bifidobacterium lactisDIETARY_SUPPLEMENT

5 billion active Bifidobacterium lactis

Bifidobacterium lactis plus İnülinMaltodextrinİnulin
Bifidobacterium lactis plus İnülinDIETARY_SUPPLEMENT

5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given

Also known as: 5 billion Bifidobacterium lactis plus 900 mg İnülin
Bifidobacterium lactisMaltodextrinİnulin
MaltodextrinOTHER

Maltodextrin

Bifidobacterium lactisBifidobacterium lactis plus İnülinİnulin
İnulinDIETARY_SUPPLEMENT

900 mg inulin per day will be given

Bifidobacterium lactisBifidobacterium lactis plus İnülinMaltodextrin

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • VLBW infants admitted to NICU at the first 7 days of life

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Related Publications (2)

  • 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.

    PMID: 22572829BACKGROUND

  • 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.

    PMID: 25596096DERIVED

Related Links

MeSH Terms

Conditions

Enterocolitis, NecrotizingSepsis

Interventions

maltodextrinInulin

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Dilek Dilli, MD

    Assoc Prof

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Dilli, Assoc Prof

CONTACT

00903123055000

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

December 24, 2012

First Posted

March 8, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

TU(4)