GERDPhase 3NCT00324532
to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
A Phase 3 study testing ProBactrix in people with GERD, run by BioBalance Corporation at 1 site in Israel.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GERD
- What is being tested?
- ProBactrix
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- GERD
- Being tested
- ProBactrix
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProBactrixDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in one or more GI symptoms (heartburn, regurgitation, bloating, epigastric pain, abdominal pain and general well being).
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startMay 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioBalance Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Braverman, Principal investigator, Shaarei Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324532
- Sponsor's protocol ID
- BB 07 2005
- Status last verified
- May 2006
- First submitted
- 9 May 2006
- Last updated
- 27 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00324532
- Acronym / sponsor ID
- BB 07 2005
- Conditions
- GERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioBalance CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- May 2007 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProBactrix | Drug | – |
Primary outcome
improvement in one or more GI symptoms (heartburn, regurgitation, bloating, epigastric pain, abdominal pain and general well being).
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Braverman principal investigator
Shaarei Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ProBactrix in people with GERD, run by BioBalance Corporation at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in one or more GI symptoms (heartburn, regurgitation, bloating, epigastric pain, abdominal pain and general well being).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.