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Proton Pump Inhibitors and Gastrointestinal Symptoms

NCT02054455 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-02-04

No results posted yet for this study

Summary

The aim of the study is to evaluate the potential protective effect of Lactobacillus paracasei subspecies paracasei F19 administration on bowel symptom onset in patients with gastro-esophageal reflux disease at long-term PPI treatment.

Conditions

  • Gastrointestinal Symptoms
  • Small Intestinal Overgrowth

Interventions

DIETARY_SUPPLEMENT

Lactobacillus paracasei F19

25x10E9 live bacterial cells for 3 days/week for 6 months

DIETARY_SUPPLEMENT

Placebo

Placebo will consist of a preparation similar to that of probiotic but with no added microorganisms.

Sponsors & Collaborators

  • University of Catanzaro

    collaborator OTHER

  • Ospedale Nuovo Regina Margherita di Roma Dr. Salvatore Campo

    collaborator UNKNOWN

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Italy

Study Locations

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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 NCT02054455 on ClinicalTrials.gov