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NCT Number: NCT01531179

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Very Low Birth Weight Infants

Age range

1 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit

Ankara, Turkey, 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

Drug

Lactobacillus reuteri 100 million CFU/day for 3 months

Other names: BioGaia

Placebo

Drug

Placebo for 3 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effect of Lactobacillus reuteri on culture proved sepsis

    Time frame: up to 6 months

    Patients with culture positivity will accept as proven sepsis.

  2. Effect of Lactobacillus reuteri on weight gain

    Time frame: up to 6 months

    The infants will be weight daily on scales that will calibrated weekly.

  3. Effect of Lactobacillus reuteri on length of hospital stay

    Time frame: up to 6 months

    Specified length of hospital stay as days

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2012
Registry last updated
May 13, 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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