<?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>IRCT20211214053401N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-02</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>ٍEffect of butyrate in ulcerative colitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of postbiotic butyrate supplementation on the expression of circadian genes, inflammation, sleep quality and psychological factors in patients with ulcerative colitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60644</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Thirty eligible individuals are divided into 2 groups by block randomization method. The blocks are made by an out-of-study person and the assignment group is placed in a sealed envelope for each individual. After entering the study, by opening the envelope, the person will be informed of the assigned group, which are named with the letters A or B, Blinding description: In this double-blind randomized controlled trial, a person outside the study labels butyrate and placebo supplements with the letters A or B for blinding. Supplements and placebos are similar in appearance and physical properties. Assignment groups are also named based on the name assigned to the supplement and placebo. As a result, participants and researchers become blind. Also, people who evaluate the consequences and analyze the data will be blind to the groups. It should be noted that at the beginning of the study, participants are informed that they are in one of the supplement or placebo groups.</study_design>
      <phase>4</phase>
      <hc_freetext>Ulcerative Colitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patients take butyrate capsules at a dose of 600 mg once a day for 12 weeks with dietary recommendations for IBD patients that take it with the main meal. Butyrate supplement is provided by Body bio company. Intervention 2: Control group: The patients take starch capsules at a dose of 600 mg once a day for 12 weeks with dietary recommendations for IBD patients that take it with the main meal.</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 Its release schedule is not yet known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Donya Firoozi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nutrition and Food Sciences, Razi blv., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۳۶۷۱۳۴۸</zip>
        <telephone>+98 71 3725 1005</telephone>
        <email>donyafiroozi@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Jalil Masoumi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz Medical Science Information Technology Development Center, Neshat St., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۳۴۸۷۴۸۵۳</zip>
        <telephone>+98 71 3233 2505</telephone>
        <email>masoumi7415@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>New case
Mild to moderate  UC
Active phase of diseases</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The patients take butyrate capsules at a dose of 600 mg once a day for 12 weeks with dietary recommendations for IBD patients that take it with the main meal. Butyrate supplement is provided by Body bio company.</i_keyword>
      <i_keyword>Control group: The patients take starch capsules at a dose of 600 mg once a day for 12 weeks with dietary recommendations for IBD patients that take it with the main meal.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Expression of circadian genes including (CRY2, Bmal1 and CLOCK). Timepoint: At the beginning of the study and 12 weeks later (end of the study). Method of measurement: Blood samples will be taken from patients to evaluate the expression of circadian rhythm genes. After isolation of peripheral blood mononuclear cells, the expression of circadian genes (CRY2, Bmal1 and CLOCK) will be evaluated by RT-PCR.</prim_outcome>
      <prim_outcome>Calprotectin. Timepoint: At the beginning of the study and 12 weeks later (end of the study). Method of measurement: For determination of fecal calprotectin level, 20 g of fecal sample will be taken from patients in the early morning and fecal calprotectin level will be measured using special commercial kits.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum level of hs-CRP. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: ELIZA commercial kit.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: PSQI questionnaire.</sec_outcome>
      <sec_outcome>Depression and anxiety. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: HADS  (Hospital anxiety depression scale) questionnaire.</sec_outcome>
      <sec_outcome>Stress. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: general health questionnaire.</sec_outcome>
      <sec_outcome>Life quality. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: IBDQ-9 self-management questionnaire.</sec_outcome>
      <sec_outcome>AST and ALT. Timepoint: Beginning of study and 12 weeks later (end of study). Method of measurement: commercial kit.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-17</approval_date>
        <contact_name>Schools of Health, Nutrition and Food Sciences - Shiraz University of Medical Sciences (Research Eth</contact_name>
        <contact_address>School of nutrition and food sciences, Razi Boulevard Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
