<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445948</url>
  </required_header>
  <id_info>
    <org_study_id>0304432</org_study_id>
    <nct_id>NCT04445948</nct_id>
  </id_info>
  <brief_title>Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy</brief_title>
  <official_title>Study the Efficacy of Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy in Egyptian Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim at evaluating the efficacy of bovine lactoferrin addition to H. Pylori&#xD;
      eradication regimens. 400 randomly distributed participants will be assigned to one of four&#xD;
      treatment regimens of H. Pylori (standard triple therapy, standard triple therapy plus bovine&#xD;
      lactoferrin, sequential therapy, or sequential therapy plus bovine lactoferrin), and&#xD;
      eradication rates will be evaluated among the four groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study included 400 patients recruited from Gastroenterology as well as general internal&#xD;
      medicine clinic at Internal Medicine department, Faculty of Medicine, University of&#xD;
      Alexandria, Egypt. After initial evaluation, every participant was randomly assigned to one&#xD;
      of four equal treatment regimens (using simple randomization, 100 patients for each regimen)&#xD;
      All included participant subjected to evaluation as regards demographic parameters, current&#xD;
      status of smoking, history of dyspepsia, epigastric pain, heartburn, melena, hematemesis,&#xD;
      nauseas / vomiting, weight loss, and dysphagia.&#xD;
&#xD;
      The diagnosis of H. Pylori infection was based on positivity of H. Pylori stool antigen&#xD;
      (HpSAg) in patients who were not indicated for upper endoscopic study / or rapid urease test&#xD;
      during esophagogastroduodenoscopy (EGD).&#xD;
&#xD;
      The HpSAg enzyme-linked immunoassay was read spectrophotometrically at 450 nm and the results&#xD;
      are recorded as negative if the optical density (O.D.) is &lt;0.14, positive if O.D. ≥0.16, and&#xD;
      equivocal for any values ≥0.14 and &lt;0.16.&#xD;
&#xD;
      Upper endoscopy was done to all patients above 45 years of age or patients with alarming&#xD;
      symptoms (melena, hematemesis, weight loss, and dysphagia) or family history of gastric&#xD;
      cancer.&#xD;
&#xD;
      Rapid urease test was done during EGD as an invasive tool for diagnosis of H.Pylori&#xD;
      infection.&#xD;
&#xD;
      After diagnosis, patients were randomly assigned as following:&#xD;
&#xD;
      group (A) received the triple therapy for 2 weeks in the form of esomeprazole 40 milligrams&#xD;
      once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily and clarithromycin&#xD;
      500 milligrams twice daily after meal; group (B) received the sequential therapy in the form&#xD;
      of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram&#xD;
      twice daily for 5 days and then esomeprazole 40 milligrams once daily 30 minutes before&#xD;
      breakfast plus metronidazole 500 milligrams twice daily and clarithromycin 500 milligrams&#xD;
      twice daily after meal for 10 days; group (C) received the triple therapy for 2 weeks in&#xD;
      addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30&#xD;
      minutes after breakfast and dinner for 14 days; group (D) received the sequential therapy in&#xD;
      addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30&#xD;
      minutes after breakfast and dinner for 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2019</start_date>
  <completion_date type="Actual">June 21, 2020</completion_date>
  <primary_completion_date type="Actual">June 21, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>H. Pylori eradication rate</measure>
    <time_frame>evaluated 28 days after last dose of treatment</time_frame>
    <description>H. Pylori eradication rate among the four groups as evaluated by negativity of H. Pylori stool antigen</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Triple Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triple Therapy plus Lactoferrin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential Therapy plus Lactoferrin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole 40 milligrams Oral Tablet</intervention_name>
    <description>Proton Pump inhibitor</description>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <arm_group_label>Sequential Therapy plus Lactoferrin</arm_group_label>
    <arm_group_label>Triple Therapy</arm_group_label>
    <arm_group_label>Triple Therapy plus Lactoferrin</arm_group_label>
    <other_name>Nexium</other_name>
    <other_name>Esompex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin 1000 milligrams tablets</intervention_name>
    <description>Penicillin derivative antibiotic</description>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <arm_group_label>Sequential Therapy plus Lactoferrin</arm_group_label>
    <arm_group_label>Triple Therapy</arm_group_label>
    <arm_group_label>Triple Therapy plus Lactoferrin</arm_group_label>
    <other_name>Amoxil</other_name>
    <other_name>Amoxicillin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin 500 milligrams Tablets</intervention_name>
    <description>Macrolide antibiotic</description>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <arm_group_label>Sequential Therapy plus Lactoferrin</arm_group_label>
    <arm_group_label>Triple Therapy</arm_group_label>
    <arm_group_label>Triple Therapy plus Lactoferrin</arm_group_label>
    <other_name>Klacid</other_name>
    <other_name>Klarithro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MetroNIDAZOLE 500 milligrams Oral Tablet</intervention_name>
    <description>Antiprotozoal</description>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <arm_group_label>Sequential Therapy plus Lactoferrin</arm_group_label>
    <other_name>Amrizole</other_name>
    <other_name>Flagyle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactoferrin Bovine sachets 200 milligrams</intervention_name>
    <description>a protein found naturally in milk from humans and cows</description>
    <arm_group_label>Sequential Therapy plus Lactoferrin</arm_group_label>
    <arm_group_label>Triple Therapy plus Lactoferrin</arm_group_label>
    <other_name>Pravotin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age group 18-60 years,&#xD;
&#xD;
          -  Positive H. Pylori test (Stool antigen / or rapid urease test)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The use of proton pump inhibitor , H2-receptor antagonist, bismuth preparation and&#xD;
             antibiotics at least 2 weeks before enrollment,&#xD;
&#xD;
          -  prior eradication treatment,&#xD;
&#xD;
          -  History of gastrectomy,&#xD;
&#xD;
          -  Equivocal H. pylori stool antigen (HpSAg) results,&#xD;
&#xD;
          -  Severe hepatic (Child Pugh class B or C) or renal diseases (eGFR &lt; 60 ml/min/1.73&#xD;
             m^2),&#xD;
&#xD;
          -  Any form of malignancy,&#xD;
&#xD;
          -  Proven allergy to clarithromycin, or Penicillin,&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh A Lashen, MD(PhD)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alexandria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21521</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Sameh A. Lashen</investigator_full_name>
    <investigator_title>Associate Professor of Internal Medicine.</investigator_title>
  </responsible_party>
  <keyword>H.pylori; Lactoferrin; triple therapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
    <mesh_term>Lactoferrin</mesh_term>
    <mesh_term>Esomeprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>data confidentiality will be preserved</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445948
org study id: 0304432
nct id: NCT04445948
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: H. Pylori eradication rate
time frame: evaluated 28 days after last dose of treatment
description: H. Pylori eradication rate among the four groups as evaluated by negativity of H. Pylori stool antigen
arm group label: Triple Therapy
arm group type: Active Comparator
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.
arm group label: Sequential Therapy
arm group type: Active Comparator
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.
arm group label: Triple Therapy plus Lactoferrin
arm group type: Active Comparator
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.
arm group label: Sequential Therapy plus Lactoferrin
arm group type: Active Comparator
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.
intervention type: Drug
intervention name: Esomeprazole 40 milligrams Oral Tablet
description: Proton Pump inhibitor
arm group label: Sequential Therapy
arm group label: Sequential Therapy plus Lactoferrin
arm group label: Triple Therapy
arm group label: Triple Therapy plus Lactoferrin
other name: Nexium
other name: Esompex
intervention type: Drug
intervention name: Amoxicillin 1000 milligrams tablets
description: Penicillin derivative antibiotic
arm group label: Sequential Therapy
arm group label: Sequential Therapy plus Lactoferrin
arm group label: Triple Therapy
arm group label: Triple Therapy plus Lactoferrin
other name: Amoxil
other name: Amoxicillin
intervention type: Drug
intervention name: Clarithromycin 500 milligrams Tablets
description: Macrolide antibiotic
arm group label: Sequential Therapy
arm group label: Sequential Therapy plus Lactoferrin
arm group label: Triple Therapy
arm group label: Triple Therapy plus Lactoferrin
other name: Klacid
other name: Klarithro
intervention type: Drug
intervention name: MetroNIDAZOLE 500 milligrams Oral Tablet
description: Antiprotozoal
arm group label: Sequential Therapy
arm group label: Sequential Therapy plus Lactoferrin
other name: Amrizole
other name: Flagyle
intervention type: Drug
intervention name: Lactoferrin Bovine sachets 200 milligrams
description: a protein found naturally in milk from humans and cows
arm group label: Sequential Therapy plus Lactoferrin
arm group label: Triple Therapy plus Lactoferrin
other name: Pravotin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sameh A Lashen, MD(PhD)
role: Principal Investigator
affiliation: University of Alexandria
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Sameh A. Lashen
investigator title: Associate Professor of Internal Medicine.
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Clarithromycin
mesh term: Lactoferrin
mesh term: Esomeprazole
sharing ipd: No
ipd description: data confidentiality will be preserved