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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Esomeprazole 40 milligrams Oral Tablet; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet; Drug: Lactoferrin Bovine sachets 200 milligrams

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Triple Therapy; Received triple therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 gram tablets twice daily and clarithromycin 500 milligrams tablets twice daily after meal for 14 days.	Drug: Esomeprazole 40 milligrams Oral Tablet; Proton Pump inhibitor; Other Names: Nexium; Esompex; Drug: Amoxicillin 1000 milligrams tablets; Penicillin derivative antibiotic; Other Names: Amoxicillin; Amoxil; Drug: Clarithromycin 500 milligrams Tablets; Macrolide antibiotic; Other Names: Klacid; Klarithro
Active Comparator: Sequential Therapy; Received the sequential therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 g tablets twice daily for 5 days, then esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus metronidazole 500 milligrams tablets twice daily plus clarithromycin 500 milligrams tablets twice daily after meal for another 10 days.	Drug: Esomeprazole 40 milligrams Oral Tablet; Proton Pump inhibitor; Other Names: Nexium; Esompex; Drug: Amoxicillin 1000 milligrams tablets; Penicillin derivative antibiotic; Other Names: Amoxicillin; Amoxil; Drug: Clarithromycin 500 milligrams Tablets; Macrolide antibiotic; Other Names: Klacid; Klarithro; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet; Antiprotozoal; Other Names: Amrizole; Flagyle
Active Comparator: Triple Therapy plus Lactoferrin; Received triple therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 gram tablets twice daily and clarithromycin 500 milligrams tablets twice daily after meal for 14 days. in addition to 200 milligrams of bovine lactoferrin sachets twice daily 30 minutes after breakfast and dinner for 14 days.	Drug: Esomeprazole 40 milligrams Oral Tablet; Proton Pump inhibitor; Other Names: Nexium; Esompex; Drug: Amoxicillin 1000 milligrams tablets; Penicillin derivative antibiotic; Other Names: Amoxicillin; Amoxil; Drug: Clarithromycin 500 milligrams Tablets; Macrolide antibiotic; Other Names: Klacid; Klarithro; Drug: Lactoferrin Bovine sachets 200 milligrams; a protein found naturally in milk from humans and cows; Other Names: Pravotin
Active Comparator: Sequential Therapy plus Lactoferrin; 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, then esomeprazole 40 mg once daily 30 minutes before breakfast plus metronidazole 500 milligrams twice daily plus clarithromycin 500 milligrams twice daily after meal for another 10 days in addition to 200 milligrams of bovine lactoferrin sachets twice daily 30 minutes after breakfast and dinner throughout the 15 days.	Drug: Esomeprazole 40 milligrams Oral Tablet; Proton Pump inhibitor; Other Names: Nexium; Esompex; Drug: Amoxicillin 1000 milligrams tablets; Penicillin derivative antibiotic; Other Names: Amoxicillin; Amoxil; Drug: Clarithromycin 500 milligrams Tablets; Macrolide antibiotic; Other Names: Klacid; Klarithro; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet; Antiprotozoal; Other Names: Amrizole; Flagyle; Drug: Lactoferrin Bovine sachets 200 milligrams; a protein found naturally in milk from humans and cows; Other Names: Pravotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. Pylori eradication rate	H. Pylori eradication rate among the four groups as evaluated by negativity of H. Pylori stool antigen	evaluated 28 days after last dose of treatment

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: University of Alexandria
• Investigators: Principal Investigator: Sameh A Lashen, MD(PhD), University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Actual): June 21, 2020
• Study Completion (Actual): June 21, 2020

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: H.pylori; Lactoferrin; triple therapy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Amoxicillin; Clarithromycin; Esomeprazole; Lactoferrin
• Other Study ID Numbers: 0304432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data confidentiality will be preserved

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No