to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
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.