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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Clarithromycin 500 milligrams Tablets; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet; Drug: Esomeprazole 40 milligrams Oral Tablet; Drug: Amoxicillin 1000 milligrams tablets; Drug: Lactoferrin Bovine sachets 200 milligrams

Study type: Interventional

Funder types: Other

Identifiers

NCT04445948

0304432

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 4 patient groups

Triple Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Amoxicillin 1000 milligrams tablets

Drug: Esomeprazole 40 milligrams Oral Tablet

Drug: Clarithromycin 500 milligrams Tablets

Sequential Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Amoxicillin 1000 milligrams tablets

Drug: Esomeprazole 40 milligrams Oral Tablet

Drug: MetroNIDAZOLE 500 milligrams Oral Tablet

Drug: Clarithromycin 500 milligrams Tablets

Triple Therapy plus Lactoferrin

Active Comparator group

Description:

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.

Treatment:

Drug: Lactoferrin Bovine sachets 200 milligrams

Drug: Amoxicillin 1000 milligrams tablets

Drug: Esomeprazole 40 milligrams Oral Tablet

Drug: Clarithromycin 500 milligrams Tablets

Sequential Therapy plus Lactoferrin

Active Comparator group

Description:

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.

Treatment:

Drug: Lactoferrin Bovine sachets 200 milligrams

Drug: Amoxicillin 1000 milligrams tablets

Drug: Esomeprazole 40 milligrams Oral Tablet

Drug: MetroNIDAZOLE 500 milligrams Oral Tablet

Drug: Clarithromycin 500 milligrams Tablets