Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effects of Lactobacillus Reuteri in Premature Infants (Reuteri)

This study has been terminated.
(Poor recruitment)
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Teresa del Moral, University of Miami Identifier:
First received: August 2, 2010
Last updated: May 9, 2017
Last verified: May 2017

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.

Condition Intervention
Premature Infant Disease
Dietary Supplement: Lactobacillus reuteri
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Administration of probiotic Lactobacillus Reuteri
Masking: Participant, Care Provider, Investigator
Masking Description:
Administration of placebo
Primary Purpose: Prevention
Official Title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns

Resource links provided by NLM:

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Time to reach full feeds [ Time Frame: First 40 days after birth ]
    Days to reach full feeds from the day feeds are started

Secondary Outcome Measures:
  • Intestinal colonization [ Time Frame: 0-6 months after birth ]
    PCR quantification of lactobacillus reuteri in the stools

  • Intestinal immunological response [ Time Frame: 0-6 months ]
    Quantification immunological markers in the stools

Enrollment: 65
Study Start Date: July 2010
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotic group
Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day
Dietary Supplement: Lactobacillus reuteri
Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
Placebo Comparator: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.
Other: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.

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

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01181791

Hospital Sotero del Rio
Santiago, Chile
Pontifica Universidad Catolica
Santiago, Chile
Sponsors and Collaborators
University of Miami
Pontificia Universidad Catolica de Chile
Principal Investigator: Teresa del Moral, MD, MPH University of Miami
  More Information

Responsible Party: Teresa del Moral, Associate Professor, University of Miami Identifier: NCT01181791     History of Changes
Other Study ID Numbers: 20090924
Study First Received: August 2, 2010
Last Updated: May 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Miami:
premature infants
feeding tolerance

Additional relevant MeSH terms:
Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases processed this record on May 22, 2017