Clinical trial NCT04445948: Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy
Official title: Study the Efficacy of Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy in Egyptian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: H.pylori; Lactoferrin; triple therapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: University of Alexandria
First posted: 2020-06-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: H. Pylori eradication rate
timeFrame: evaluated 28 days after last dose of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: University of Alexandria
name: Sameh A Lashen, MD(PhD)
role: PRINCIPAL_INVESTIGATOR
References: