Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

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.
    

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 initial evaluation, every participant was randomly assigned to one
      of four equal treatment regimens (using simple randomization, 100 patients for each regimen)
      All included participant subjected to evaluation as regards demographic parameters, current
      status of smoking, history of dyspepsia, epigastric pain, heartburn, melena, hematemesis,
      nauseas / vomiting, weight loss, and dysphagia.

      The diagnosis of H. Pylori infection was based on positivity of H. Pylori stool antigen
      (HpSAg) in patients who were not indicated for upper endoscopic study / or rapid urease test
      during esophagogastroduodenoscopy (EGD).

      The HpSAg enzyme-linked immunoassay was read spectrophotometrically at 450 nm and the results
      are recorded as negative if the optical density (O.D.) is <0.14, positive if O.D. ≥0.16, and
      equivocal for any values ≥0.14 and <0.16.

      Upper endoscopy was done to all patients above 45 years of age or patients with alarming
      symptoms (melena, hematemesis, weight loss, and dysphagia) or family history of gastric
      cancer.

      Rapid urease test was done during EGD as an invasive tool for diagnosis of H.Pylori
      infection.

      After diagnosis, patients were randomly assigned as following:

      group (A) received the triple therapy for 2 weeks in the form of esomeprazole 40 milligrams
      once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily and clarithromycin
      500 milligrams twice daily after meal; group (B) received the sequential therapy in the form
      of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram
      twice daily for 5 days and then esomeprazole 40 milligrams once daily 30 minutes before
      breakfast plus metronidazole 500 milligrams twice daily and clarithromycin 500 milligrams
      twice daily after meal for 10 days; group (C) received the triple therapy for 2 weeks in
      addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30
      minutes after breakfast and dinner for 14 days; group (D) received the sequential therapy in
      addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30
      minutes after breakfast and dinner for 14 days.
    

Intervention name(s): Esomeprazole 40 milligrams Oral Tablet; Amoxicillin 1000 milligrams tablets; Clarithromycin 500 milligrams Tablets; MetroNIDAZOLE 500 milligrams Oral Tablet; Lactoferrin Bovine sachets 200 milligrams
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Proton Pump inhibitor; Penicillin derivative antibiotic; Macrolide antibiotic; Antiprotozoal; a protein found naturally in milk from humans and cows
Other intervention name(s): Nexium; Esompex; Amoxil; Amoxicillin; Klacid; Klarithro; Amrizole; Flagyle; Pravotin
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Lactoferrin; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: H.pylori; Lactoferrin; triple therapy