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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT01980095
Eligibility Criteria:
Inclusion Criteria:
1. Be ≥18 years of age and ≤ 65 years
2. Have symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals)
3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test
4. Be informed of the nature of the study and provide written informed consent before any study specific procedures are performed (or have a legally authorized representative sign consent)
Exclusion Criteria:
1. Have alarm symptoms/signs (including unexplained anemia \[iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss)
2. Have taken antibiotics in the 4 weeks prior to screening
3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening
4. Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer
5. Have a history of gastric outlet obstruction
6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome
7. Have a history of gastric cancer
8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01980095
Study Brief:
Protocol Section:
NCT01980095