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The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Primary Purpose

Necrotizing Enterocolitis, Sepsis

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bifidobacterium lactis

Bifidobacterium lactis plus İnülin

Maltodextrin

İnulin

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring Necrotizing enterocolitis, Sepsis, Length of hospital stay, Mortality

Eligibility Criteria

undefined - 30 Days (Child)All SexesAccepts 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

Sites / Locations

Şevket Yılmaz Research HospitalRecruiting
Diyarbakır Research HospitalRecruiting
Okmeydani Research HospitalRecruiting
Umraniye Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Bifidobacterium lactis

İnulin

Maltodextrin

Bifidobacterium lactis plus İnülin

Arm Description

5 billion Bifidobacterium lactis

900 mg İnulin per day will be given

Maltodextrin

5 billion active Bifidobacterium lactis plus 900 mg İnülin per day

Outcomes

Primary Outcome Measures

Necrotizing enterocolitis

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

Secondary Outcome Measures

length of hospital stay

Full Information

NCT ID

NCT01807858

First Posted

December 24, 2012

Last Updated

March 7, 2013

Sponsor

Dr. Sami Ulus Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01807858

Brief Title

The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Official Title

The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dr. Sami Ulus Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Necrotizing Enterocolitis, Sepsis

Keywords

Necrotizing enterocolitis, Sepsis, Length of hospital stay, Mortality

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bifidobacterium lactis

Arm Type

Active Comparator

Arm Description

5 billion Bifidobacterium lactis

Arm Title

İnulin

Arm Type

Active Comparator

Arm Description

900 mg İnulin per day will be given

Arm Title

Maltodextrin

Arm Type

Placebo Comparator

Arm Description

Maltodextrin

Arm Title

Bifidobacterium lactis plus İnülin

Arm Type

Active Comparator

Arm Description

5 billion active Bifidobacterium lactis plus 900 mg İnülin per day

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidobacterium lactis

Intervention Description

5 billion active Bifidobacterium lactis

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidobacterium lactis plus İnülin

Other Intervention Name(s)

5 billion Bifidobacterium lactis plus 900 mg İnülin

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Maltodextrin

Intervention Description

Maltodextrin

Intervention Type

Dietary Supplement

Intervention Name(s)

İnulin

Intervention Description

900 mg inulin per day will be given

Primary Outcome Measure Information:

Title

Necrotizing enterocolitis

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

length of hospital stay

Description

length of hospital stay

Time Frame

16 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

30 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dilek Dilli, Assoc Prof

Phone

00903123055000

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dilek Dilli, MD

Organizational Affiliation

Assoc Prof

Official's Role

Principal Investigator

Facility Information:

Facility Name

Şevket Yılmaz Research Hospital

City

Bursa

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arzu Akdağ, MD

First Name & Middle Initial & Last Name & Degree

Arzu Akdağ, MD

Facility Name

Diyarbakır Research Hospital

City

Diyarbakır

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Banu Mutlu, MD

First Name & Middle Initial & Last Name & Degree

M. Şah Oğuz, MD

Facility Name

Okmeydani Research Hospital

City

İstanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Özden Turan, MD

First Name & Middle Initial & Last Name & Degree

Özden Turan

First Name & Middle Initial & Last Name & Degree

Özden Turan, MD

Facility Name

Umraniye Research Hospital

City

İstanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Şenol Bozdağ, MD

First Name & Middle Initial & Last Name & Degree

Şenol Bozdağ

12. IPD Sharing Statement

Citations:

PubMed Identifier

22572829

Citation

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.

Results Reference

background

PubMed Identifier

25596096

Citation

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.

Results Reference

derived

Links:

URL

http://www.livestrong.com/article/468506-are-probiotics-safe-for-newborns/

Description

Are Probiotics Safe For Newborns? | LIVESTRONG.COM

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The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants

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