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

NCT04445948 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-06-25

No results posted yet for this study

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

Interventions

DRUG

Esomeprazole 40 milligrams Oral Tablet

Proton Pump inhibitor

DRUG

Amoxicillin 1000 milligrams tablets

Penicillin derivative antibiotic

DRUG

Clarithromycin 500 milligrams Tablets

Macrolide antibiotic

DRUG

MetroNIDAZOLE 500 milligrams Oral Tablet

Antiprotozoal

DRUG

Lactoferrin Bovine sachets 200 milligrams

a protein found naturally in milk from humans and cows

Sponsors & Collaborators

  • University of Alexandria

    collaborator OTHER

  • Alexandria University

    lead OTHER

Principal Investigators

  • Sameh A Lashen, MD(PhD) · University of Alexandria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-06-21
Completion
2020-06-21

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445948 on ClinicalTrials.gov