to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Non Comparative, Prospective Pilot Study, to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD|
- improvement in one or more GI symptoms (heartburn, regurgitation, bloating, epigastric pain, abdominal pain and general well being).
- symptomatic response comparison between patients with a positive versus negative breath test for bacterial overgrowth
- negative breath test for bacterial overgrowth in the patients with positive breath test at entry
|Study Start Date:||May 2006|
|Study Completion Date:||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324532
|Shaarei Zedek Medical Center|
|Principal Investigator:||Braverman||Shaarei Zedek Medical Center|