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Completed

NCT Number: NCT01531192

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

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.

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Key information

Conditions

Very Low Birth Weight Infants

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology

Ankara, 06110, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

Lactobacillus reuteri 100 million CFU/day for 3 months

Other names: BioGaia

Nystatin

Drug

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

Other names: Mikostatin

Primary outcomes

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

    Time frame: up to 6 months

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

Secondary outcomes

  1. Effect of Lactobacillus reuteri on feeding intolerance

    Time frame: up to 6 months

    Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)

  2. Effect of Lactobacillus reuteri on sepsis

    Time frame: up to 6 months

    Patients with culture positivity will accept as proven sepsis.

  3. Effect of Lactobacillus reuteri on length of hospital stay

    Time frame: up to 6 months

    Specified length of hospital stay as days.

  4. Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants

    Time frame: up to 6 months

    NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2012
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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