Status:
COMPLETED
Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy
Lead Sponsor:
Alexandria University
Collaborating Sponsors:
University of Alexandria
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The investigators aim at evaluating the efficacy of bovine lactoferrin addition to H. Pylori eradication regimens. 400 randomly distributed participants will be assigned to one of four treatment regim...
Detailed Description
the study included 400 patients recruited from Gastroenterology as well as general internal medicine clinic at Internal Medicine department, Faculty of Medicine, University of Alexandria, Egypt. After...
Eligibility Criteria
Inclusion
- Age group 18-60 years,
- Positive H. Pylori test (Stool antigen / or rapid urease test)
Exclusion
- The use of proton pump inhibitor , H2-receptor antagonist, bismuth preparation and antibiotics at least 2 weeks before enrollment,
- prior eradication treatment,
- History of gastrectomy,
- Equivocal H. pylori stool antigen (HpSAg) results,
- Severe hepatic (Child Pugh class B or C) or renal diseases (eGFR \< 60 ml/min/1.73 m\^2),
- Any form of malignancy,
- Proven allergy to clarithromycin, or Penicillin,
- Pregnant or lactating females.
Key Trial Info
Start Date :
November 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04445948
Start Date
November 30 2019
End Date
June 21 2020
Last Update
June 25 2020
Active Locations (1)
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1
Faculty of Medicine
Alexandria, Egypt, 21521