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

Primary Purpose

GERD

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
ProBactrix
Sponsored by
BioBalance Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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) -

Sites / Locations

  • Shaarei Zedek Medical Center

Outcomes

Primary Outcome Measures

improvement in one or more GI symptoms (heartburn, regurgitation, bloating, epigastric pain, abdominal pain and general well being).

Secondary Outcome Measures

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
safety

Full Information

First Posted
May 9, 2006
Last Updated
January 26, 2015
Sponsor
BioBalance Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00324532
Brief Title
to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
BioBalance Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ProBactrix
Primary Outcome Measure Information:
Title
improvement in one or more GI symptoms (heartburn, regurgitation, bloating, epigastric pain, abdominal pain and general well being).
Secondary Outcome Measure Information:
Title
symptomatic response comparison between patients with a positive versus negative breath test for bacterial overgrowth
Title
negative breath test for bacterial overgrowth in the patients with positive breath test at entry
Title
safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Braverman
Organizational Affiliation
Shaarei Zedek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaarei Zedek Medical Center
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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