NCT01531192

Brief Summary

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 16, 2013

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

February 4, 2012

Last Update Submit

July 13, 2013

Conditions

Very Low Birth Weight Infants

Keywords

Lactobacillus reuteriNystatinVery Low Birth Weight InfantsCandida Colonization

Outcome Measures

Primary Outcomes (1)

  • Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants

    Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.

    up to 6 months

Secondary Outcomes (4)

  • Effect of Lactobacillus reuteri on feeding intolerance

    up to 6 months

  • Effect of Lactobacillus reuteri on sepsis

    up to 6 months

  • Effect of Lactobacillus reuteri on length of hospital stay

    up to 6 months

  • Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants

    up to 6 months

Study Arms (2)

Lactobacillus reuteri

EXPERIMENTAL

Lactobacillus reuteri 100 million CFU/day for 3 months

Dietary Supplement: Lactobacillus reuteri

Nystatin

ACTIVE COMPARATOR

50000 unit/3 times a day

Drug: Nystatin

Interventions

Lactobacillus reuteriDIETARY_SUPPLEMENT

Lactobacillus reuteri 100 million CFU/day for 3 months

Also known as: BioGaia
Lactobacillus reuteri
NystatinDRUG

50000 unit/3 times a day, both for orally and by orogastric route

Also known as: Mikostatin
Nystatin

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Very low birth weight infants \< 1500 gr
  • Gestational age \< 32 weeks

You may not qualify if:

  • Genetic anomalies
  • Short bowel syndrome
  • Not willing to participate
  • Allergy to Lactobacillus reuteri components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (1)

  • Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9.

    PMID: 25245226DERIVED

Related Links

MeSH Terms

Interventions

Nystatin

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Mehmet Yekta Oncel, MD

    Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2012

First Posted

February 10, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 16, 2013

Record last verified: 2012-02

Locations

TU(1)