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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445948
• Other study ID #: 0304432
• Status: Completed
• Phase: Phase 4
• Start date: November 30, 2019
• Est. completion date: June 21, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 21, 2020
• Est. primary completion date: June 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Esomeprazole 40 milligrams Oral Tablet
Proton Pump inhibitor
• Amoxicillin 1000 milligrams tablets
Penicillin derivative antibiotic
• Clarithromycin 500 milligrams Tablets
Macrolide antibiotic
• MetroNIDAZOLE 500 milligrams Oral Tablet
Antiprotozoal
• Lactoferrin Bovine sachets 200 milligrams
a protein found naturally in milk from humans and cows

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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