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

NCT01531179 | Completed Phase 3

• 1 other identifier: ZTB6303
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotizing Enterocolitis; Very Low Birth Weight Infants

Outcome Measures

Primary Outcomes (1)

• Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants

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

  up to 6 months

Secondary Outcomes (3)

• Effect of Lactobacillus reuteri on culture proved sepsis

  up to 6 months

• Effect of Lactobacillus reuteri on weight gain

  up to 6 months

• Effect of Lactobacillus reuteri on length of hospital stay

  up to 6 months

Study Arms (2)

Lactobacillus reuteri

EXPERIMENTAL

Lactobacillus reuteri 100 million CFU/day for 3 months

Drug: Lactobacillus reuteri

Control

PLACEBO COMPARATOR

Placebo for 3 months

Drug: Placebo

Interventions

Lactobacillus reuteri DRUG

Lactobacillus reuteri 100 million CFU/day for 3 months

Also known as: BioGaia

Lactobacillus reuteri

Placebo DRUG

Placebo for 3 months

Control

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit

Ankara, Turkey, 06110, Turkey (Türkiye)

Location

Related Publications (1)

• Oncel MY, Sari FN, Arayici S, Guzoglu N, Erdeve O, Uras N, Oguz SS, Dilmen U. Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F110-5. doi: 10.1136/archdischild-2013-304745. Epub 2013 Dec 5.

  PMID: 24309022 DERIVED

Related Links

• Lactobacillus reuteri

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Mehmet Yekta Oncel, MD

  Neonatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• 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: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-02

Locations

TU (1)