<?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>IRCT20200915048726N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-05</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of synbiotics in the treatment of patients with halitosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of probiotics in the treatment of patients with halitosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>47</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72874</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Halitosis.</hc_freetext>
      <i_freetext>Intervention group: Patients who are eligible to participate in the study will receive a diet of probiotic capsules every 12 hours. Open a Fami Lact capsule of Bio Fermentation Company and dissolve it in 50cc of water and gargle and swallowed it once in the morning after breakfast and once at night before going to bed and after brushing your teeth (the patient should not use mouthwash while studying) ), this method is used for one month. All patients will be educated about potential side effects and will be monitored during treatment to assess for side effects, which are very uncommon, and for proper use. All patients are asked to record any side effects that occur during treatment, including diarrhea, constipation, dyspepsia, bloating, and skin rash. Severe side effects are defined as complications that disrupt daily activities and require the patient to stop treatment, which is very rare..</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:
All data can be shared when participants are not identifiable

When:
Ability to access data 6 months after publishing the results

To whom:
The data will be available to academic researchers and non-academic physicians

Conditions:
Perform other analyzes and extract more results

Where to obtain:
Please refer to the e-mail address of the corresponding author

How to obtain:
Submit a request to the Deputy of research and technology of the University / Refer the request to the relevant author of the project

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Imam Khomeini Hospital</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3337 4977</telephone>
        <email>arash_6z@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Imam Khomeini Hospital</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816633131</zip>
        <telephone>+98 11 3337 4977</telephone>
        <email>arash_6z@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 18 to 60 years
Halitosis with an Organoleptic (OLT) score of two and above, which is subjectively determined by the doctor and objectively by the person herself
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of infection and active inflammation of the nose and pharynx in examination and history
History of sensitivity to probiotics
The presence of infection and active inflammation of the mouth and teeth in examination and history
Advanced renal failure
Cirrhosis of the liver
The patient's lack of consent to participate or the desire to withdraw from the study
Use of immunosuppressive drugs
Pregnancy and breastfeeding
Use of mouthwash and mouth fresheners during the study
Patients with typical symptoms GERD or peptic ulcer
Use of antibiotics in the last month
Recent surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R19.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Halitosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients who are eligible to participate in the study will receive a diet of probiotic capsules every 12 hours. Open a Fami Lact capsule of Bio Fermentation Company and dissolve it in 50cc of water and gargle and swallowed it once in the morning after breakfast and once at night before going to bed and after brushing your teeth (the patient should not use mouthwash while studying) ), this method is used for one month. All patients will be educated about potential side effects and will be monitored during treatment to assess for side effects, which are very uncommon, and for proper use. All patients are asked to record any side effects that occur during treatment, including diarrhea, constipation, dyspepsia, bloating, and skin rash. Severe side effects are defined as complications that disrupt daily activities and require the patient to stop treatment, which is very rare.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of halitosis. Timepoint: before treatment (day zero); Day 15; Day 30 (end of treatment); Day 45 and Day 60. Method of measurement: based on organoleptic score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: before treatment (day zero); Day 15; Day 30 (end of treatment). Method of measurement: evaluation checklist.</sec_outcome>
      <sec_outcome>Remission rate. Timepoint: before treatment (day zero); Day 15; Day 30 (end of treatment); Day 45 and Day 60. Method of measurement: based on organoleptic score.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-10</approval_date>
        <contact_name>Ethics committee of mazandaran University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Hospital, Razi St sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
