Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

NCT ID: NCT01531192

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Very Low Birth Weight Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

Group Type EXPERIMENTAL

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus reuteri 100 million CFU/day for 3 months

Nystatin

50000 unit/3 times a day

Group Type ACTIVE_COMPARATOR

Nystatin

Intervention Type DRUG

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

Interventions

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Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Nystatin

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

Intervention Type DRUG

Other Intervention Names

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BioGaia Mikostatin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Genetic anomalies
* Short bowel syndrome
* Not willing to participate
* Allergy to Lactobacillus reuteri components
Minimum Eligible Age

1 Day

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Yekta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Yekta Oncel, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatology

Locations

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Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 25245226 (View on PubMed)

Other Identifiers

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ZTB630301

Identifier Type: -

Identifier Source: org_study_id

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