<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20151128025274N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-28</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of concurrent Omega-3 and Cranberry juice consumption on eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with Helicobacter pylori infection</public_title>
      <acronym></acronym>
      <scientific_title>Effects of concurrent Omega-3 and Cranberry juice consumption on eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with Helicobacter pylori infection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28997</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using randomized blocked categorization (4 block based on BMI and sex), individuals will be placed in one of the three intervention groups or in the control group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Helicobacter pylori.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Two weeks of helicobacter pylori triple therapy, including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g + cranberry juice (400 ml) ) Enriched with omega 3 (two grams). Intervention 2: Intervention group: Two weeks of helicobacter pylori triple therapy, including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g + cranberry juice (400 ml) ). Intervention 3: Intervention group: Two weeks of helicobacter pylori triple therapy, including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g + omega-3 (two grams). Intervention 4: Control group: Two weeks of helicobacter pylori triple therapy, including including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Maghsoumi-Nourozabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway, faculty of paramedicine, Department of nutrition, Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715751</zip>
        <telephone>+98 61 3373 8330</telephone>
        <email>l.maghsumi55@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Zare Javid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Highway, Faculty of Paramedicine, Department of Nutrition,Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715751</zip>
        <telephone>+98 61 3373 8330</telephone>
        <email>ahmaddjavid@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 65 years old
Helicobacter pylori infection
Gastrointestinal complaints
Body mass index 18.5 to 35 kg / m2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of drug therapy to eradicate Helicobacter pylori infection
Stomach surgery
History of peptic ulcer and gastrointestinal malignancies
Having any disease that causes inflammation and increased levels of inflammatory markers, such as diabetes, cardiovascular disease, respiratory infections such as asthma and ...
Getting immunodeficiency diseases
Developing chronic diseases requiring drug treatment
Taking medications other than prescription drugs
Receiving antibiotics or proton pump inhibitors or H2 blockers over the past 2 months
Taking omega supplementation At least 3 months before the start of the study
Use of any diet supplements During the study 3 months before the start of the study
Changes in the diet during the study period
Consumption of less than 80% of the supplements delivered to the patient during the study period.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Two weeks of helicobacter pylori triple therapy, including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g + cranberry juice (400 ml) ) Enriched with omega 3 (two grams)</i_keyword>
      <i_keyword>Intervention group: Two weeks of helicobacter pylori triple therapy, including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g + cranberry juice (400 ml) )</i_keyword>
      <i_keyword>Intervention group: Two weeks of helicobacter pylori triple therapy, including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g + omega-3 (two grams)</i_keyword>
      <i_keyword>Control group: Two weeks of helicobacter pylori triple therapy, including including daily intake of pantoprazole 80 mg , amoxicillin 2 g, bismuth 8 mg and clarithromycin 1 g</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative cases of Helicobacter pylori infection. Timepoint: Three weeks after the end of treatment. Method of measurement: Checking of H.Pylori stool antigen.</prim_outcome>
      <prim_outcome>Scale of gastrointestinal complaints questionnaire from Helicobacter pylori infection. Timepoint: Before and at the end of the study. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Serum levels of Il-17, TGFβ1 and INF-γ. Timepoint: Before and at the end of the study. Method of measurement: ELISA method.</prim_outcome>
      <prim_outcome>Serum levels of TAC and MDA. Timepoint: Before and after study. Method of measurement: ELISA method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-05</approval_date>
        <contact_name>Ethics committee of Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Highway, Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
