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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324532
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : January 27, 2015
Information provided by:
BioBalance Corporation

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.

Condition or disease Intervention/treatment Phase
GERD Drug: ProBactrix Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Actual Study Completion Date : May 2007

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

Secondary Outcome Measures :
  1. symptomatic response comparison between patients with a positive versus negative breath test for bacterial overgrowth
  2. negative breath test for bacterial overgrowth in the patients with positive breath test at entry
  3. safety

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age between ≥18 and ≤80, males and females.
  2. Patient administered PPI therapy for GERD.
  3. Patient suffers from any GI symptoms including GERD symptoms despite PPI therapy for at least 60 days
  4. 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
  5. Able to give informed consent
  6. 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324532

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Shaarei Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
BioBalance Corporation
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Principal Investigator: Braverman Shaarei Zedek Medical Center
Layout table for additonal information Identifier: NCT00324532    
Other Study ID Numbers: BB 07 2005
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: May 2006
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases