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 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT02726269
Eligibility Criteria:
Inclusion Criteria:
1. Male or female adult subjects who wish to participate after signing the informed consent.
2. Aged between 18 and 65 years.
3. HP infection diagnosed by endoscopic gastric biopsy.
4. Subjects who fulfill the following HP eradication criteria according to Maastricht 3 Consensus Report:
* Non ulcer dyspepsia with gastric biopsy positive for HP infection,
* Uncomplicated duodenal ulcer (without active bleeding, perforation or stenosis) with gastric biopsy positive for HP infection,
* Uncomplicated benign gastric ulcer (without active bleeding, perforation or stenosis) with gastric biopsy positive for HP infection,
* Chronic intake of NSAIDs with gastric biopsy positive for HP infection without active gastrointestinal bleeding.
Exclusion Criteria:
1. Pregnant or lactating women.
2. Subjects who have previously received the PLA or CLA treatment.
3. Subjects who are diagnosed by endoscopy with upper gastrointestinal bleeding secondary to active peptic ulcer (gastric or duodenal) with injuries classified in any of the following stages of the Forrest Classification: I-a (Spurting hemorrhage), I-b (Oozing hemorrhage), II-a (Visible vessel) or II-b (Adherent clot).
4. Subjects who are diagnosed by endoscopy with upper gastrointestinal bleeding by erosive gastritis secondary to active NSAID with positive biopsy for HP infection and whose clinical conditions require hospitalization and / or blood transfusion.
5. Subjects with psychiatric disorders including eating disorders.
6. Subjects with chronic degenerative diseases including uncontrolled hepatic, renal or endocrine diseases (except diabetes controlled by oral hypoglycemic agents or controlled hypothyroidism), malabsorption or chronic diarrhea, history of seizures or epilepsy, gastric surgery or subjects with oncological diseases.
7. Subjects with previous allergic reactions to any of the treatment components: Pantoprazole, Amoxicillin, Clarithromycin, Azithromycin or Levofloxacin.
8. Subjects with a history of photosensitivity or tendinitis secondary to quinolones intake.
9. Subjects who are taking any of the following medications:
* NSAIDS: Fenbufen
* ergot
* Oral anticoagulants
* Cyclosporine
* Digoxin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02726269
Study Brief:
Protocol Section:
NCT02726269