Effects of Lactobacillus Reuteri in Premature Infants

Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181791

Acronym

Reuteri

Enrollment

Registered

2010-08-13

Start date

2010-07-31

Completion date

2017-07-31

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Infant Disease

Keywords

probiotics, premature infants, feeding tolerance

Brief summary

This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants. The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

Detailed description

The primary outcome days to achieve full feeds will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live

Interventions

DIETARY_SUPPLEMENTLactobacillus reuteri

Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day

OTHERPlacebo

The placebo consists of an identical formulation except that the L. reuteri is not present.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Administration of placebo

Intervention model description

Administration of probiotic Lactobacillus Reuteri

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Inclusion criteria

* Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days

Exclusion criteria

* Chromosomal anomalies. * Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia) * Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention * Parental refusal * Prior enrollment into a conflicting clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Time to reach full feeds	First 40 days after birth	Days to reach full feeds from the day feeds are started

Secondary

Measure	Time frame	Description
Intestinal colonization	0-6 months after birth	PCR quantification of lactobacillus reuteri in the stools
Intestinal immunological response	0-6 months	Quantification immunological markers in the stools

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026