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to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD

NCT00324532 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-01-27

No results posted yet for this study

Summary

The study is an Open Label, Prospective, Non Comparative, Pilot, clinical trial design. Patients with inadequate relief in GI symptoms associated with GERD despite PPI treatment will be screened and those who meet the inclusion and exclusion criteria will perform a glucose breath test for bacterial overgrowth . Each patient will then complete a questionnaire to record their GERD related symptoms. Each patient will then receive a daily intake of 30 mL two times daily, 30 minutes before meals for a period of 4 weeks. During the course of the trial, they will have 4 visits with the study physician to assess treatment compliance and occurrence of adverse events, and will complete periodic daily diaries to record compliance.

Conditions

  • GERD

Interventions

DRUG

ProBactrix

Sponsors & Collaborators

  • BioBalance Corporation

    lead INDUSTRY

Principal Investigators

  • Braverman · Shaarei Zedek Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Completion
2007-05-31

Countries

  • Israel

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 NCT00324532 on ClinicalTrials.gov