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Effect of Lactobacillus Reuteri in Cystic Fibrosis

NCT01737983 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2012-11-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri

Lactobacillus reuteri was administered in 5 drops per day (10\^10 colony-forming units) for 6 months.

DIETARY_SUPPLEMENT

placebo

The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

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 NCT01737983 on ClinicalTrials.gov