Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-24 @ 10:02 PM
NCT ID:
NCT00324532
Eligibility Criteria:
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)
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00324532
Study Brief:
Protocol Section:
NCT00324532