Prophylactic Probiotics to Extremely Low Birth Weight Prematures

Summary

Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition.

The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.

Conditions

• Feeding; Difficult, Newborn
• Growth Failure
• Necrotizing Enterocolitis
• Sepsis

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day

DIETARY_SUPPLEMENT

Placebo

Oil drops without Lactobacillus reuteri

Sponsors & Collaborators

• BioGaia AB

  collaborator INDUSTRY

• Ekhaga Foundation, Sweden

  collaborator UNKNOWN

• Medical Research Council of Southeast Sweden

  collaborator OTHER_GOV

• University Hospital, Linkoeping

  collaborator OTHER

• The Swedish Research Council

  collaborator OTHER_GOV

• The Swedish Society of Medicine

  collaborator OTHER

• Ostergotland County Council, Sweden

  lead OTHER

Principal Investigators

• Thomas Abrahamsson, MD, PhD · Linköping University Hospital; County Council of Östergötland

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

3 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Sweden

Study Locations