Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy

• Status: Completed
• Trial end date: 2020-06-21
• Target enrollment: 0
• Participant gender: All

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 regimens of H. Pylori (standard triple therapy, standard triple therapy plus bovine lactoferrin, sequential therapy, or sequential therapy plus bovine lactoferrin), and eradication rates will be evaluated among the four groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Collaborator: University of Alexandria
• Treatments: Amoxicillin; Clarithromycin; Esomeprazole; Lactoferrin; Metronidazole

Criteria

Inclusion Criteria:

• Age group 18-60 years,

• Positive H. Pylori test (Stool antigen / or rapid urease test)

Exclusion Criteria:

• 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.