<?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>IRCT2017080135408N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-12</date_registration>
      <primary_sponsor>Research Center for Infectious Diseases of the Digestive System, Vice Chancellor research of Ahvaz J</primary_sponsor>
      <public_title>The influence of probiotics and Zinc on the patients with non-alcoholic fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>The influence of probiotics and Zinc on the serum levels of liver enzymes and lipid profile in  patients with non-alcoholic fatty liver disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26762</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-alcoholic fatty liver disease.</hc_freetext>
      <i_freetext>Intervention 1: Two protexin probiotic capsules 600 mg (Probiotics international, United Kingdom) and two zinc sulfate capsules 25 mg (Alhavi, Iran)are used daily, at noon and at night after meals, for three months.&#13;
The  protexin capsule contains 7 species of probiotics. Include Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum and Lactobacillus bulgaricus. Intervention 2: Two protexin probiotic capsules 600 mg (Probiotics international, United Kingdom) and two zinc placebo capsules are used daily, at noon and at night after meals, for three months.   &#13;
The  protexin capsule contains 7 species of probiotics. Include Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum and Lactobacillus bulgaricus. Intervention 3: Two capsules of probiotic placebo and two zinc sulfate capsules 25 mg (Alhavi, Iran) are used daily, at noon and at night after meals, for three months. Intervention 4: Two probiotic placebo capsules and two zinc placebo capsules are used daily, at noon and at night after meals, for three months.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Masoumeh Khedri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3221 6104</telephone>
        <email>khedri.m@ajums.ac.ir</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Masoumeh Khedri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 3221 6104</telephone>
        <email>khedri.m@ajums.ac.ir   -     khedrimasoumeh@gmail.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with non-alcoholic fatty liver disease &#13;
Exclusion criteria: autoimmune hepatitis- viral hepatitis- liver metabolic diseases- liver metabolic disease- drugs and toxins inception- age below 18- History of receiving medication for NAFLD- History of kidney or heart disease- Taking amiodarone, methotrexate, tamoxifen, glucocorticoids, sodium valproate and anti HIV drugs.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K76.0</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Two protexin probiotic capsules 600 mg (Probiotics international, United Kingdom) and two zinc sulfate capsules 25 mg (Alhavi, Iran)are used daily, at noon and at night after meals, for three months.&#13;
The  protexin capsule contains 7 species of probiotics. Include Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum and Lactobacillus bulgaricus.</i_keyword>
      <i_keyword>Two protexin probiotic capsules 600 mg (Probiotics international, United Kingdom) and two zinc placebo capsules are used daily, at noon and at night after meals, for three months.   &#13;
The  protexin capsule contains 7 species of probiotics. Include Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum and Lactobacillus bulgaricus.</i_keyword>
      <i_keyword>Two capsules of probiotic placebo and two zinc sulfate capsules 25 mg (Alhavi, Iran) are used daily, at noon and at night after meals, for three months.</i_keyword>
      <i_keyword>Two probiotic placebo capsules and two zinc placebo capsules are used daily, at noon and at night after meals, for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ALT. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>AST. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>FBS. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Total cholesterol. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>HDL. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>LDL. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>CRP. Timepoint: Before and 3 months after intervention. Method of measurement: Blood test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Weight. Timepoint: Before and 3 months after intervention. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Body mass index (BMI). Timepoint: Before and 3 months after intervention. Method of measurement: Body mass is expressed in units of kg/m2.</sec_outcome>
      <sec_outcome>Waist. Timepoint: Before and 3 months after intervention. Method of measurement: Centimeter.</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>Research Center for Infectious Diseases of the Digestive System, Vice Chancellor research of Ahvaz J</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-22</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishpour University of Medical Sciences</contact_name>
        <contact_address>Khuzestan, Ahvaz, Golestan, Ahvaz Jundishpour University of Medical Sciences Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
