<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265730</url>
  </required_header>
  <id_info>
    <org_study_id>Hacettepe01</org_study_id>
    <nct_id>NCT03265730</nct_id>
  </id_info>
  <brief_title>Pediatric Antibiotic Associated Diarrhea</brief_title>
  <acronym>TURPENADA</acronym>
  <official_title>Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be&#xD;
      encountered between two hours to two months after starting of antibiotics. The purpose of the&#xD;
      study is to determine incidence,risk factors and severity of pediatric antibiotic associated&#xD;
      diarrhea in Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients&#xD;
      either early during treatment or up to two months after the cessation of the treatment. The&#xD;
      frequency differs according to the definition of diarrhea, the inciting antimicrobial agent&#xD;
      and the host factors such geriatric age, immunosuppression, prolonged hospitalization. Almost&#xD;
      all agents, especially the the ones acting on anaerobes may cause diarrhea. Clinical&#xD;
      presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. In Turkey&#xD;
      still data about antibiotic associated diarrhea is not enough. Incidence and the factors that&#xD;
      effect severity are not known.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey</measure>
    <time_frame>December 2018</time_frame>
    <description>How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local differences in pediatric AAD across Turkey</measure>
    <time_frame>December 2018</time_frame>
    <description>Differences in incidence and severity of AAD in children in different cities in Turkey.&#xD;
The incidence of antibiotic associated diarrhea will be expressed as proportion of new cases of diarrhea to total number of patients in the follow-up period of patients who receive oral antibiotics. The overall ratio will be calculated at the end of whole study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.</measure>
    <time_frame>December 2018</time_frame>
    <description>Duration of AAD and interventional requirements of pediatric patients who develop AAD.&#xD;
Development of diarrhea during study period will be determined by using Bristol Stool Charts. Stool charts will be provided to parents by the investigators. The parents will follow number and shape and consistency of stool , and decide according to the Bristol Stool Chart. Four times and more defecation and stool in type 5,6 and 7 according to Bristol Chart that will continue for a minimum of 2 days will be regarded as diarrhea. If the diarrhea necessitates hospitalization and/or intravenous hydration therapy, this will be regarded as severe diarrhea. If patient with diarrhea will treated by just observation and diarrhea will subside spontaneously, diarrhea will be regarded as mild.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic</measure>
    <time_frame>December 2018</time_frame>
    <description>Incidence of antibiotic associated diarrhea with different class of antibiotics will be determined</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of antibiotic associated diarrhea in different age groups</measure>
    <time_frame>December 2018</time_frame>
    <description>Differences in incidence and severity of AAD in children with different age groups.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Diarrhea</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children who admit to outpatient clinics and are ordered oral antibiotics for acute&#xD;
        infections such as upper and lower respiratory tract infections, infections of mouth,&#xD;
        urinary tract infections, skin and soft tissue infections.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The parents and the child who give consent&#xD;
&#xD;
          -  The children who are treated for the acute infections in the outpatient clinics and&#xD;
             whole treatment is completed in the outpatient clinics.&#xD;
&#xD;
          -  Children who are born mature, for the children who are younger than 1 year of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The parents and child who do not give consent&#xD;
&#xD;
          -  Children who have primary and secondary immunosuppressive states.&#xD;
&#xD;
          -  Children who had abdominal/gastrointestinal tract surgery in the past.&#xD;
&#xD;
          -  Children who had used probiotics/prebiotics in the last one month period.&#xD;
&#xD;
          -  Children who had used antibiotics in the last one month period.&#xD;
&#xD;
          -  Children who has accompanying gastrointestinal symptoms.&#xD;
&#xD;
          -  Children who are using anti-acid treatment at the time of involvement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ates Kara, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sevgen Tanır Basaranoglu, MD</last_name>
    <phone>+ 90 532 7498624</phone>
    <email>sevgent@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ates Kara, Professor</last_name>
    <phone>+90 532 4135130</phone>
    <email>ateskara@me.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sevgen Tanır Basaranoglu, MD</last_name>
      <phone>+90 532 7498624</phone>
      <email>sevgent@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ates Kara, Professor</last_name>
      <phone>+ 90 532 4135130</phone>
      <email>ateskara@me.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Wistrom J, Norrby SR, Myhre EB, Eriksson S, Granstrom G, Lagergren L, Englund G, Nord CE, Svenungsson B. Frequency of antibiotic-associated diarrhoea in 2462 antibiotic-treated hospitalized patients: a prospective study. J Antimicrob Chemother. 2001 Jan;47(1):43-50. doi: 10.1093/jac/47.1.43.</citation>
    <PMID>11152430</PMID>
  </reference>
  <reference>
    <citation>Lau CS, Chamberlain RS. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016 Feb 22;9:27-37. doi: 10.2147/IJGM.S98280. eCollection 2016.</citation>
    <PMID>26955289</PMID>
  </reference>
  <reference>
    <citation>Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ. 2002 Jun 8;324(7350):1345-6. doi: 10.1136/bmj.324.7350.1345. No abstract available.</citation>
    <PMID>12052785</PMID>
  </reference>
  <reference>
    <citation>Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S, Orel R, Shamir R, Vandenplas Y, van Goudoever JB, Weizman Z; ESPGHAN Working Group for ProbioticsPrebiotics. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):495-506. doi: 10.1097/MPG.0000000000001081.</citation>
    <PMID>26756877</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>March 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 28, 2017</last_update_submitted>
  <last_update_submitted_qc>November 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ates Kara</investigator_full_name>
    <investigator_title>Prof Dr</investigator_title>
  </responsible_party>
  <keyword>Outpatient clinics</keyword>
  <keyword>oral antibiotics</keyword>
  <keyword>diarrhea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265730
org study id: Hacettepe01
nct id: NCT03265730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be
      encountered between two hours to two months after starting of antibiotics. The purpose of the
      study is to determine incidence,risk factors and severity of pediatric antibiotic associated
      diarrhea in Turkey.
Antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients
      either early during treatment or up to two months after the cessation of the treatment. The
      frequency differs according to the definition of diarrhea, the inciting antimicrobial agent
      and the host factors such geriatric age, immunosuppression, prolonged hospitalization. Almost
      all agents, especially the the ones acting on anaerobes may cause diarrhea. Clinical
      presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. In Turkey
      still data about antibiotic associated diarrhea is not enough. Incidence and the factors that
      effect severity are not known.
observational model: Cohort
time perspective: Prospective
measure: Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey
time frame: December 2018
description: How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.
measure: Local differences in pediatric AAD across Turkey
time frame: December 2018
description: Differences in incidence and severity of AAD in children in different cities in Turkey.
The incidence of antibiotic associated diarrhea will be expressed as proportion of new cases of diarrhea to total number of patients in the follow-up period of patients who receive oral antibiotics. The overall ratio will be calculated at the end of whole study period.
measure: Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.
time frame: December 2018
description: Duration of AAD and interventional requirements of pediatric patients who develop AAD.
Development of diarrhea during study period will be determined by using Bristol Stool Charts. Stool charts will be provided to parents by the investigators. The parents will follow number and shape and consistency of stool , and decide according to the Bristol Stool Chart. Four times and more defecation and stool in type 5,6 and 7 according to Bristol Chart that will continue for a minimum of 2 days will be regarded as diarrhea. If the diarrhea necessitates hospitalization and/or intravenous hydration therapy, this will be regarded as severe diarrhea. If patient with diarrhea will treated by just observation and diarrhea will subside spontaneously, diarrhea will be regarded as mild.
measure: Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic
time frame: December 2018
description: Incidence of antibiotic associated diarrhea with different class of antibiotics will be determined
measure: Incidence of antibiotic associated diarrhea in different age groups
time frame: December 2018
description: Differences in incidence and severity of AAD in children with different age groups.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: Ates Kara, Professor
role: Principal Investigator
affiliation: Hacettepe University
last name: Sevgen Tanır Basaranoglu, MD
phone: + 90 532 7498624
email: sevgent@gmail.com
last name: Ates Kara, Professor
phone: +90 532 4135130
email: ateskara@me.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
citation: Wistrom J, Norrby SR, Myhre EB, Eriksson S, Granstrom G, Lagergren L, Englund G, Nord CE, Svenungsson B. Frequency of antibiotic-associated diarrhoea in 2462 antibiotic-treated hospitalized patients: a prospective study. J Antimicrob Chemother. 2001 Jan;47(1):43-50. doi: 10.1093/jac/47.1.43.
PMID: 11152430
citation: Lau CS, Chamberlain RS. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016 Feb 22;9:27-37. doi: 10.2147/IJGM.S98280. eCollection 2016.
PMID: 26955289
citation: Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ. 2002 Jun 8;324(7350):1345-6. doi: 10.1136/bmj.324.7350.1345. No abstract available.
PMID: 12052785
citation: Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S, Orel R, Shamir R, Vandenplas Y, van Goudoever JB, Weizman Z; ESPGHAN Working Group for ProbioticsPrebiotics. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):495-506. doi: 10.1097/MPG.0000000000001081.
PMID: 26756877
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ates Kara
investigator title: Prof Dr
mesh term: Diarrhea
sharing ipd: No