Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324532
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2006-05-09
Brief Title:
to Assess the Efficacy and Safety of the Probiotic E Coli Strain M17 on Patients With GERD
Sponsor:
BioBalance Corporation
Organization:
BioBalance Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None