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

NCT04445948 | Completed Phase 4

• 1 other identifier: 0304432
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

H.pylori; Lactoferrin; triple therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Triple Therapy

ACTIVE COMPARATOR

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; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets

Sequential Therapy

ACTIVE COMPARATOR

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; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet

Triple Therapy plus Lactoferrin

ACTIVE COMPARATOR

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; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets; Drug: Lactoferrin Bovine sachets 200 milligrams

Sequential Therapy plus Lactoferrin

ACTIVE COMPARATOR

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

Interventions

Esomeprazole 40 milligrams Oral Tablet DRUG

Proton Pump inhibitor

Also known as: Nexium, Esompex

Sequential Therapy; Sequential Therapy plus Lactoferrin; Triple Therapy; Triple Therapy plus Lactoferrin

Amoxicillin 1000 milligrams tablets DRUG

Penicillin derivative antibiotic

Also known as: Amoxil, Amoxicillin

Sequential Therapy; Sequential Therapy plus Lactoferrin; Triple Therapy; Triple Therapy plus Lactoferrin

Clarithromycin 500 milligrams Tablets DRUG

Macrolide antibiotic

Also known as: Klacid, Klarithro

Sequential Therapy; Sequential Therapy plus Lactoferrin; Triple Therapy; Triple Therapy plus Lactoferrin

MetroNIDAZOLE 500 milligrams Oral Tablet DRUG

Antiprotozoal

Also known as: Amrizole, Flagyle

Sequential Therapy; Sequential Therapy plus Lactoferrin

Lactoferrin Bovine sachets 200 milligrams DRUG

a protein found naturally in milk from humans and cows

Also known as: Pravotin

Sequential Therapy plus Lactoferrin; Triple Therapy plus Lactoferrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group 18-60 years,
• Positive H. Pylori test (Stool antigen / or rapid urease test)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• University of Alexandria: collaborator

Study Sites (1)

Faculty of Medicine

Alexandria, 21521, Egypt

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Sameh A Lashen, MD(PhD)

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine.

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 24, 2020
• Study Start: November 30, 2019
• Primary Completion: June 21, 2020
• Study Completion: June 21, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)