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

NCT ID: NCT01531179

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

Group Type: EXPERIMENTAL

Lactobacillus reuteri

Intervention Type: DRUG

Lactobacillus reuteri 100 million CFU/day for 3 months

Control

Placebo for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for 3 months

Interventions

Lactobacillus reuteri

Lactobacillus reuteri 100 million CFU/day for 3 months

Intervention Type: DRUG

Placebo

Placebo for 3 months

Intervention Type: DRUG

Other Intervention Names

BioGaia

Eligibility Criteria

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

Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Yekta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Yekta Oncel, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatology

Locations

Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit

Ankara, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 24309022 (View on PubMed)

Related Links

http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=L040030000&QV1=LACTOBACILLUS+REUTERI

Lactobacillus reuteri

Other Identifiers

ZTB6303

Identifier Type: -

Identifier Source: org_study_id