Helicobacter Pylori Infection Clinical Trial
Official title:
Study the Efficacy of Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy in Egyptian Patients
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.
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.
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