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The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns

NCT00985816 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-11-08

No results posted yet for this study

Summary

The investigators propose a Phase II interventional trial to investigate the role of Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature infants and further evaluate safety of the use of this probiotic in a population of premature infants.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Reuteri

L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Flavia Indrio · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985816 on ClinicalTrials.gov