Infloran® for Prevention of Necrotizing Enterocolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Total Enrollment

463 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-10-31

Brief Summary

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

Necrotizing enterocolitis (NEC) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity.

The pathogenesis of NEC remains largely unclear, but it is widely considered as a multifactorial disease. Prematurity, enteral feeding, bacterial colonisation of the gut and intestinal ischemia have been proposed as major risk factors.

Probiotics may prevent NEC by improving the maturity and function of the gut mucosal barrier, modulating the immune system, promoting colonization of the gut with beneficial organisms and preventing colonization by pathogens.

A variety of clinical trials have evaluated the effect of different probiotic preparations on the occurrence of NEC in preterm infants. The results of recent metaanalyses suggest a benefit of probiotic bacteria in reducing the incidence of NEC and propose a change of practice.

The aim of the study is to evaluate the efficacy of the probiotic preparation Infloran® in reducing the incidence of NEC after implementation in clinical routine in preterm (\< 34 weeks gestational age) very low birth weight infants compared to a historical cohort.

Related Clinical Trials

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

Probiotics Reduce Incidence of Necrotizing Enterocolitis for Very Low Birth Weight Infants

NCT00540033

Enterocolitis, Necrotizing

TERMINATED PHASE2

Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

NCT05945017

Infant, Newborn, Diseases Infant Development

ACTIVE_NOT_RECRUITING NA

Prebiotics in the Prevention of Necrotizing Enterocolitis

NCT00437567

Necrotizing Enterocolitis

UNKNOWN PHASE2

Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics

NCT02226263

Infectious Diseases

COMPLETED PHASE2

PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

NCT06501404

Premature Infants Necrotizing Enterocolitis

COMPLETED NA

Detailed Description

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

Conditions

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

Necrotizing Enterocolitis

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Probiotics (Infloran)

Very low birth weight Infants receiving 2 capsules/d Infloran starting in the first week of life

No interventions assigned to this group

Control

Very low birth weight Infants who did not receive Infloran (historical cohort)

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* Neonates admitted to the neonatal intensive care unit on day 1 of life
* Very low birth weight (\<1500 gram)
* Prematurity \< 34/0 weeks gestational age
* For group receiving probiotics: 230 infants born after the 20/Sep/2010 (i.e. date of introduction of Infloran in clinical routine)
* For control group (historical): 230 infants born before 2010

Exclusion Criteria

* Malformation of the gut (omphalocele, gastroschisis, intestinal atresia)
* Death before seven days of life, except due to NEC
* Transfer to another hospital before 37 weeks of corrected gestational age, except those who were transferred to a partner clinic using the same protocol for probiotic supplementation
* For group receiving probiotics: Infants who did not receive Infloran® starting in the first week of life or stopped before 34 weeks gestational age, except infants who developed NEC (reason for discontinuation of Infloran)

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No