Status:
COMPLETED
to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
Lead Sponsor:
BioBalance Corporation
Conditions:
GERD
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- Age between ≥18 and ≤80, males and females.
- Patient administered PPI therapy for GERD.
- Patient suffers from any GI symptoms including GERD symptoms despite PPI therapy for at least 60 days
- Patient with positive or negative glucose breath test for bacterial overgrowth unless they are not able to do this secondary to diabetes. Diabetics will have a lactulose breath test
- Able to give informed consent
- Candidate will be available for the next 4 weeks
Exclusion
- 1\. Pregnant, breast-feeding, or not using approved methods of contraception (if of childbearing potential) 2. Unstable medical disorder 3. Patient has had E. coli strain M17 administered in the past month 4. History of major psychiatric disorder or substance abuse within the previous 2 years, including psychiatric illnesses requiring medication that may cause doubt in the validity of the signed Informed Consent form 5. Existing illness or medical condition that will prevent the patient from participating in the study (such as severe heart disease, insulin dependent diabetes, hyperactive thyroid gland, HIV positive, etc.) 6. Participation in another clinical study during the past four weeks. 7. Any use of a probiotic supplement within 30 days of the screening period (with the exception of standard food yogurt products) 8. Any use of antibiotics within 30 days of the screening/enrollment period (however, candidate may wait to initiate screening exam until 30 days have lapsed since antibiotic course was completed)
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Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00324532
Start Date
May 1 2006
End Date
May 1 2007
Last Update
January 27 2015
Active Locations (1)
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1
Shaarei Zedek Medical Center
Jerusalem, Israel