<?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>IRCT20121216011763N35</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-28</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>synbiotic and hypothyroidism</public_title>
      <acronym></acronym>
      <scientific_title>The effect of synbiotic supplementation on anthropometric indices, Inflammatory and hormone profiles in patients with hypothyroidism</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34286</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two synbiotic and placebo groups.The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses, Blinding description: This study is a double-blind clinical trial (participant, researcher). The familact synbiotic supplement and its placebo will be produce by Zist takhmir company . Synbiotic supplement and its placebos will in the same form of package and the patients and researcher will not aware of the content of the pack until the end of trial.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypothyroidism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A daily dose of 500 mg of FimiLact synbiotic capsule was read 2 hours after Levothyroxine tablet for 8 weeks (dosage of 1 capsule per day). Synthetic FamiLact Synthetic Foam Supplement will be manufactured by Iranian Zist Takhmir Company. Intervention 2: Control group: Each day, 1 placebo (starch 375 mg, lactose 22 mg, magnesium stearate 1 mg, 1 mg silicon dioxide, 1 mg talc) will receive 2 hours after levothyroxine for 8 weeks.The placebo will be made by Tehran  Zist Takhmir Company.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The collected deidentified for the primary outcome measure only will be shared.

When:
starting 12 months after publication.

To whom:
Available for people working in academic institutions

Conditions:
The data will provide for educational use.

Where to obtain:
Dr. Gholamreza Askari 
askari@mui.ac.ir

How to obtain:
The data will send as soon as possible, after receiving the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib Ave.</address>
        <city>Isfehan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 1378</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Gholamreza Askari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjarib streetو Isfahan University of Medical Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 3171</telephone>
        <email>askari@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18 to 65 years
Hypothyroid patients with a history of treatment for more than one year using levothyroxine (sodium)
TSH is at least one year with a constant dose of levothyroxine in the normal range
No smoking and alcohol
Non pregnant, non-lactating
Non-use of drugs that affect metabolism and absorption of levothyroxine include: iron sulfate, magnesium sulfate, warfarin, luvastatin, amiodarone, sumatropin, calcium carbonate, orlistat, multivitamin and minerals, theophylline, ritunavir, rifampin, phenytoin, karmazapine, Phenobarbital, Sucralfate, Aluminum hydroxide, Sertraline, Bile doses, Estrogens and other estrogen modifying drugs, Proton pump suppressants, Phosphate binders
People who, after explaining the work, were willing to cooperate and answer questions and conduct experiments</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Thyroid cancer
Intestinal malabsorption (history of obstructive surgery, inflammatory bowel disease, celiac disease)
Antibiotic use
Acute and chronic infectious diseases
Use of drugs that affect the absorption and metabolism of levothyroxine, including (iron sulfate, magnesium sulfate, warfarin, luvastatin, amiodarone, sumatropin, calcium carbonate, orlistat, multivitaminomineral, theophylline, ritunavir, rifampin, Tween, Karmazpine, Phenobarbital, Sucralfate, Aluminum Hydroxide, Sertraline, Bile Drug, Estrogen and other estrogen modifying drugs, proton pump inhibitor drugs, phosphate binders)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E03.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypothyroidism, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A daily dose of 500 mg of FimiLact synbiotic capsule was read 2 hours after Levothyroxine tablet for 8 weeks (dosage of 1 capsule per day). Synthetic FamiLact Synthetic Foam Supplement will be manufactured by Iranian Zist Takhmir Company.</i_keyword>
      <i_keyword>Control group: Each day, 1 placebo (starch 375 mg, lactose 22 mg, magnesium stearate 1 mg, 1 mg silicon dioxide, 1 mg talc) will receive 2 hours after levothyroxine for 8 weeks.The placebo will be made by Tehran  Zist Takhmir Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thyroid-stimulating hormone. Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
      <prim_outcome>Free triiodothyronine (FT3). Timepoint: Before the start of the study and 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anti-thyroid peroxidase. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA).</sec_outcome>
      <sec_outcome>C-reactive protein. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Laboratory analysis.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Digital scale.</sec_outcome>
      <sec_outcome>Waist Circumference. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: non-stretching tape measure.</sec_outcome>
      <sec_outcome>Waist / hip ratio - WHR. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: non-stretching tape measure.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Sphygmomonometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Sphygmomonometer.</sec_outcome>
      <sec_outcome>Body Mass Index. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Dividing the weight into kilograms by squared height by meter.</sec_outcome>
      <sec_outcome>Depression score. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21).</sec_outcome>
      <sec_outcome>Anxiety score. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21).</sec_outcome>
      <sec_outcome>Stress score. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scales (DASS-21).</sec_outcome>
      <sec_outcome>Appetite. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Visual Analogue Scale.</sec_outcome>
      <sec_outcome>Multidimensional Fatigue Inventory. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: multidimensional fatigue inventory (MFI-20).</sec_outcome>
      <sec_outcome>Fatigue Intensity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Fatigue severity scale (FSS).</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: World Health Organization Quality of Life Questionnaire 26 questions (WHOQOL-BREF).</sec_outcome>
      <sec_outcome>Constipation , bowel habits, abdominal symptoms. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Constipation , bowel habits, abdominal symptoms questionnaire.</sec_outcome>
      <sec_outcome>Body fat percentage. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Bioimpedance.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-19</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezarjarib Ave., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
