Prophylactic Probiotics to Extremely Low Birth Weight Prematures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

NCT05604846

Necrotizing Enterocolitis Death Sepsis Newborn +2 more

RECRUITING NA

Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

NCT01164124

Low Birth Weight

COMPLETED PHASE2/PHASE3

Probiotics and Early Microbial Contact in Preterm Neonates

NCT01454661

Premature; Infant, Light-for-dates Breastfeeding

UNKNOWN NA

Bifidobacterium Supplementation for Very Low Birth Weight Infants

NCT01375309

Preterm Infants

COMPLETED NA

Prebiotic in Preventing Low Birth Weight

NCT02721225

Birth Weight <2500gm Genitourinary Tract Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

RATIONALE 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 (NEC), and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition. There is scientific evidence that dietary supplements with probiotics may have an effect on these manifestations.

Lactobacillus reuteri is a well studied probiotic bacterium that has been tested in several clinical studies in premature infants and older children, and the results of these studies and animal studies suggest that this bacterium may also have an effect on growth and mortality in extremely premature infants. Lactobacillus reuteri reduces colonization with pathogenic microbes, stimulates gastric and intestinal motility and shortens hospital stay in moderately premature infants. In animal models, L. reuteri also induces anti-inflammatory immune responses, reduces the symptoms of inflammatory bowel disease and the incidence of NEC. Administration of L. reuteri also improves the intestinal barrier both in human studies in children and in animal studies. Dietary supplements of L. reuteri to extremely premature infants may therefore improve feeding tolerance and nutrition and reduce the incidence of severe complications in this population.

HYPOTHESIS Premature infants with extremely low birth weight receiving daily supplements of Lactobacillus reuteri DSM 17938 will reach full enteral feeding faster compared with children receiving placebo.

STUDY DESIGN This study will be conducted as a prospective multi-center double blind placebo-controlled study in neonatal intensive care units in Sweden. In total 134 neonates with extremely low birth weight (\<1000g) and gestational age \<28+0 weeks will be randomized to receive either dietary supplements of Lactobacillus reuteri or placebo. Study product will be identical to the active and placebo group besides the addition of Lactobacillus reuteri (1.25 x 100 million bacteria=0.2 ml oil drops per day) in the active group. The supplementation will commence within 1-3 days after birth and will be given daily until gestational week 36+0. The infants will be followed until gestational week 36+0 and data on feeding tolerance, nutrition, growth, infections, NEC, bronchopulmonary dysplasia, death, and potential confounders will be entered in an individual study protocol. Stool, breast milk, and blood samples will be collected for analyses of possible underlying mechanisms.

A 2-year follow up including examination by pediatrician, growth parameters, questionnaire and psychology testing (Bayley´s test) will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding; Difficult, Newborn Growth Failure Necrotizing Enterocolitis Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactobacillus reuteri

Lactobacillus reuteri DSM 17938, 125 million bacteria/day

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

The same oil drops as the active study product but without Lactobacillus reuteri

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Oil drops without Lactobacillus reuteri

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus reuteri

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oil drops without Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Birth weight \< 1000 g
* Gestational age: v23+0-V27 +6.
* Age \< 72 hours at inclusion.
* Signed informed consent by parents.

Exclusion Criteria

* Fatal or complex congenital malformation at inclusion time.
* Chromosomal defect at inclusion time.
* No realistic hope of survival at inclusion time.
* Gastrointestinal malformation at inclusion time.
* Participation in another study which aims to influence nutrition, growth, feeding tolerance or necrotizing enterocolitis.

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes