<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/NCT01696656</url>
  </required_header>
  <id_info>
    <org_study_id>Gutadjuvant1</org_study_id>
    <secondary_id>0540/11</secondary_id>
    <nct_id>NCT01696656</nct_id>
  </id_info>
  <brief_title>Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency</brief_title>
  <official_title>Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with&#xD;
      significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition&#xD;
      as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and&#xD;
      symptom-relieving agents may be required. Prescriptional pattern of these drugs will be&#xD;
      analyzed in a clinical cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with&#xD;
      significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition&#xD;
      as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and&#xD;
      symptom-relieving agents may be required. Little attention has been given to the indications&#xD;
      and dosage schedules of such drugs, many of which are employed as off-label prescriptions&#xD;
      because of lack of official guidelines.&#xD;
&#xD;
      Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home&#xD;
      parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das&#xD;
      Clinicas, Sao Paulo, Brazil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major gastrointestinal adjuvant prescription</measure>
    <time_frame>Last 12 months</time_frame>
    <description>The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major antibiotic adjuvant prescription</measure>
    <time_frame>Last 12 months</time_frame>
    <description>Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Main vitamin/mineral adjuvant prescription</measure>
    <time_frame>Last 12 months</time_frame>
    <description>Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">37</enrollment>
  <condition>Intestinal Insufficiency</condition>
  <condition>Short Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Intestinal insufficiency</arm_group_label>
    <description>Patients with variable categories of major intestinal resection due to benign diseases,suffering from intestinal insufficiency and maintained with home nutritional support. Only clinically stable and nonhospitalized subjects will be recruited.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug prescription pattern</intervention_name>
    <description>Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records</description>
    <arm_group_label>Intestinal insufficiency</arm_group_label>
    <other_name>Gastrointestinal drugs</other_name>
    <other_name>Antibiotics</other_name>
    <other_name>Vitamins</other_name>
    <other_name>Minerals</other_name>
    <other_name>General drugs</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with short bowel syndrome secondary to trauma, Crohn´s disease, mesenteric&#xD;
        thrombosis, radiation enteritis and other conditions, suffering from intestinal&#xD;
        insufficiency and undergoing home-parenteral or enteral nutrition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Home nutritional support longer than 12 months,full records and return&#xD;
        visits available at the hospital system.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Critical illness, death, discontinuation of nutritional therapy,&#xD;
        registered for intestinal transplantation, additional gastrointestinal operations for short&#xD;
        bowel syndrome (valves, lengthening) or for other conditions (gallbladder disease,&#xD;
        intestinal obstruction, necrosis, infection).&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruna Z Godoy, RPh</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Tilg H. Short bowel syndrome: searching for the proper diet. Eur J Gastroenterol Hepatol. 2008 Nov;20(11):1061-3. doi: 10.1097/MEG.0b013e3283040cc9.</citation>
    <PMID>19047836</PMID>
  </reference>
  <reference>
    <citation>Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current management of short bowel syndrome. Curr Probl Surg. 2012 Feb;49(2):52-115. doi: 10.1067/j.cpsurg.2011.10.002. No abstract available.</citation>
    <PMID>22244264</PMID>
  </reference>
  <reference>
    <citation>Efsen E, Jeppesen PB. Modern treatment of adult short bowel syndrome patients. Minerva Gastroenterol Dietol. 2011 Dec;57(4):405-17.</citation>
    <PMID>22105729</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Joel Faintuch</investigator_full_name>
    <investigator_title>Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School</investigator_title>
  </responsible_party>
  <keyword>Gastrointestinal drugs</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Vitamins</keyword>
  <keyword>Minerals</keyword>
  <keyword>Intestinal insufficiency</keyword>
  <keyword>Short Bowel syndrome</keyword>
  <keyword>Adjuvant therapy</keyword>
  <keyword>Antacids</keyword>
  <keyword>Gastrointestinal motility modifiers</keyword>
  <keyword>Micronutrients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Short Bowel Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Gastrointestinal Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01696656
org study id: Gutadjuvant1
secondary id: 0540/11
nct id: NCT01696656
lead sponsor: 
has dmc: No
Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with
      significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition
      as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and
      symptom-relieving agents may be required. Prescriptional pattern of these drugs will be
      analyzed in a clinical cohort.
Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with
      significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition
      as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and
      symptom-relieving agents may be required. Little attention has been given to the indications
      and dosage schedules of such drugs, many of which are employed as off-label prescriptions
      because of lack of official guidelines.

      Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home
      parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das
      Clinicas, Sao Paulo, Brazil.
observational model: Cohort
time perspective: Retrospective
measure: Major gastrointestinal adjuvant prescription
time frame: Last 12 months
description: The most prescribed adjuvant agent for alleviation of gastrointestinal troubles such as diarrhea, malabsorption or gastric hypersecretion.
measure: Major antibiotic adjuvant prescription
time frame: Last 12 months
description: Principal antibiotic employed for suspected or actual bacterial overgrowth associated with diarrhea, malabsorption or systemic aberrations.
measure: Main vitamin/mineral adjuvant prescription
time frame: Last 12 months
description: Vitamin, mineral or other micronutrient required for correction of nutrition deficiency, not available or poorly absorbed via current parenteral/enteral nutrition regimen
arm group label: Intestinal insufficiency
description: Patients with variable categories of major intestinal resection due to benign diseases,suffering from intestinal insufficiency and maintained with home nutritional support. Only clinically stable and nonhospitalized subjects will be recruited.
intervention type: Drug
intervention name: Drug prescription pattern
description: Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records
arm group label: Intestinal insufficiency
other name: Gastrointestinal drugs
other name: Antibiotics
other name: Vitamins
other name: Minerals
other name: General drugs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bruna Z Godoy, RPh
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
citation: Tilg H. Short bowel syndrome: searching for the proper diet. Eur J Gastroenterol Hepatol. 2008 Nov;20(11):1061-3. doi: 10.1097/MEG.0b013e3283040cc9.
PMID: 19047836
citation: Thompson JS, Rochling FA, Weseman RA, Mercer DF. Current management of short bowel syndrome. Curr Probl Surg. 2012 Feb;49(2):52-115. doi: 10.1067/j.cpsurg.2011.10.002. No abstract available.
PMID: 22244264
citation: Efsen E, Jeppesen PB. Modern treatment of adult short bowel syndrome patients. Minerva Gastroenterol Dietol. 2011 Dec;57(4):405-17.
PMID: 22105729
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Joel Faintuch
investigator title: Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School
mesh term: Short Bowel Syndrome
mesh term: Anti-Bacterial Agents
mesh term: Gastrointestinal Agents