<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/NCT02977897</url>
  </required_header>
  <id_info>
    <org_study_id>16-5998</org_study_id>
    <nct_id>NCT02977897</nct_id>
  </id_info>
  <brief_title>Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide</brief_title>
  <official_title>Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, observational pilot study of ten post-transplant patients presenting with&#xD;
      diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard&#xD;
      workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to&#xD;
      determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once&#xD;
      the diagnosis is confirmed, the patients will then be treated with a short course of&#xD;
      subcutaneous Octreotide which has been shown to cure this type of diarrhea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">November 2017</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>Measurement of Fecal Calprotectin levels patients with diarrhea on MMF</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment of patients with MMF induced diarrhea with Octreotide</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Diarrhea</condition>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>Diarrhea on MMF</arm_group_label>
    <description>Solid organ transplant recipients on MMF who develop diarrhea while taking the drug. Fecal calprotectin will be measured in their stool and Octreotide Acetate will be used to treat their diarrhea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide Acetate</intervention_name>
    <description>Octreotide 100mcg SC q12h for 5 days</description>
    <arm_group_label>Diarrhea on MMF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males and females between the ages of 18 and 75 years who are solid organ transplant&#xD;
        recipients on mycophenolate mofetil (MMF) referred to gastroenterology at Toronto General&#xD;
        Hospital for diarrhea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients between the ages of 18 and 75 years old who are solid organ&#xD;
             transplant recipients followed at Toronto General Hospital on MMF referred to&#xD;
             gastroenterology for diarrhea.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with a known history of IBD or GVHD of the bowel.&#xD;
&#xD;
          2. Any subject receiving Octreotide for another indication.&#xD;
&#xD;
          3. Any patient unable to undergo endoscopy.&#xD;
&#xD;
          4. Any patient with a contraindication to Octreotide therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Flavio Habal, MD</last_name>
    <phone>4163405023</phone>
    <email>dr.flavio.habal@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Toronto General Hospital, University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Flavio Habal, MD, PhD</last_name>
      <phone>4163405023</phone>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Maes B, Hadaya K, de Moor B, Cambier P, Peeters P, de Meester J, Donck J, Sennesael J, Squifflet JP. Severe diarrhea in renal transplant patients: results of the DIDACT study. Am J Transplant. 2006 Jun;6(6):1466-72. doi: 10.1111/j.1600-6143.2006.01320.x. Erratum In: Am J Transplant. 2007 Mar;7(3):729. Am J Transplant. 2007 May;7(5):1317.</citation>
    <PMID>16686772</PMID>
  </reference>
  <reference>
    <citation>Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. doi: 10.1016/s0162-3109(00)00188-0.</citation>
    <PMID>10878285</PMID>
  </reference>
  <reference>
    <citation>Knoll GA, MacDonald I, Khan A, Van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol. 2003 Sep;14(9):2381-6. doi: 10.1097/01.asn.0000079616.71891.f5.</citation>
    <PMID>12937317</PMID>
  </reference>
  <reference>
    <citation>Arns W. Noninfectious gastrointestinal (GI) complications of mycophenolic acid therapy: a consequence of local GI toxicity? Transplant Proc. 2007 Jan-Feb;39(1):88-93. doi: 10.1016/j.transproceed.2006.10.189.</citation>
    <PMID>17275481</PMID>
  </reference>
  <reference>
    <citation>Feichtiger H, Wieland E, Armstrong VW, Shipkova M. The acyl glucuronide metabolite of mycophenolic acid induces tubulin polymerization in vitro. Clin Biochem. 2010 Jan;43(1-2):208-13. doi: 10.1016/j.clinbiochem.2009.08.023. Epub 2009 Sep 8.</citation>
    <PMID>19744471</PMID>
  </reference>
  <reference>
    <citation>Calmet FH, Yarur AJ, Pukazhendhi G, Ahmad J, Bhamidimarri KR. Endoscopic and histological features of mycophenolate mofetil colitis in patients after solid organ transplantation. Ann Gastroenterol. 2015 Jul-Sep;28(3):366-373.</citation>
    <PMID>26126799</PMID>
  </reference>
  <reference>
    <citation>Liapis G, Boletis J, Skalioti C, Bamias G, Tsimaratou K, Patsouris E, Delladetsima I. Histological spectrum of mycophenolate mofetil-related colitis: association with apoptosis. Histopathology. 2013 Nov;63(5):649-58. doi: 10.1111/his.12222. Epub 2013 Sep 11.</citation>
    <PMID>24025088</PMID>
  </reference>
  <reference>
    <citation>Sydora MJ, Sydora BC, Fedorak RN. Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome. J Crohns Colitis. 2012 Mar;6(2):207-14. doi: 10.1016/j.crohns.2011.08.008. Epub 2011 Sep 7.</citation>
    <PMID>22325175</PMID>
  </reference>
  <reference>
    <citation>Ferreiro-Iglesias R, Barreiro-de Acosta M, Lorenzo-Gonzalez A, Dominguez-Munoz JE. Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab. Scand J Gastroenterol. 2016;51(4):442-7. doi: 10.3109/00365521.2015.1115546. Epub 2015 Nov 23.</citation>
    <PMID>26595391</PMID>
  </reference>
  <reference>
    <citation>Lorenz F, Marklund S, Werner M, Palmqvist R, Wahlin BE, Wahlin A. Fecal calprotectin as a biomarker of intestinal graft versus host disease after allogeneic hematopoietic stem cell transplantation. Sci Rep. 2015 Jan 21;5:7920. doi: 10.1038/srep07920.</citation>
    <PMID>25605402</PMID>
  </reference>
  <reference>
    <citation>Konikoff MR, Denson LA. Role of fecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Jun;12(6):524-34. doi: 10.1097/00054725-200606000-00013.</citation>
    <PMID>16775498</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diarrhea</keyword>
  <keyword>Immunosuppression</keyword>
  <keyword>Post-transplantation</keyword>
  <keyword>Octreotide</keyword>
  <keyword>Mycophenolate Mofetil</keyword>
  <keyword>Fecal Calprotectin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</mesh_term>
  </intervention_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/NCT02977897
org study id: 16-5998
nct id: NCT02977897
lead sponsor: 
has dmc: No
Prospective, observational pilot study of ten post-transplant patients presenting with
      diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard
      workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to
      determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once
      the diagnosis is confirmed, the patients will then be treated with a short course of
      subcutaneous Octreotide which has been shown to cure this type of diarrhea.
observational model: Cohort
time perspective: Prospective
measure: Measurement of Fecal Calprotectin levels patients with diarrhea on MMF
time frame: 3 months
measure: Treatment of patients with MMF induced diarrhea with Octreotide
time frame: 5 days
arm group label: Diarrhea on MMF
description: Solid organ transplant recipients on MMF who develop diarrhea while taking the drug. Fecal calprotectin will be measured in their stool and Octreotide Acetate will be used to treat their diarrhea.
intervention type: Drug
intervention name: Octreotide Acetate
description: Octreotide 100mcg SC q12h for 5 days
arm group label: Diarrhea on MMF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Flavio Habal, MD
phone: 4163405023
email: dr.flavio.habal@uhn.ca
facility: 
contact: 
country: Canada
citation: Maes B, Hadaya K, de Moor B, Cambier P, Peeters P, de Meester J, Donck J, Sennesael J, Squifflet JP. Severe diarrhea in renal transplant patients: results of the DIDACT study. Am J Transplant. 2006 Jun;6(6):1466-72. doi: 10.1111/j.1600-6143.2006.01320.x. Erratum In: Am J Transplant. 2007 Mar;7(3):729. Am J Transplant. 2007 May;7(5):1317.
PMID: 16686772
citation: Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. doi: 10.1016/s0162-3109(00)00188-0.
PMID: 10878285
citation: Knoll GA, MacDonald I, Khan A, Van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol. 2003 Sep;14(9):2381-6. doi: 10.1097/01.asn.0000079616.71891.f5.
PMID: 12937317
citation: Arns W. Noninfectious gastrointestinal (GI) complications of mycophenolic acid therapy: a consequence of local GI toxicity? Transplant Proc. 2007 Jan-Feb;39(1):88-93. doi: 10.1016/j.transproceed.2006.10.189.
PMID: 17275481
citation: Feichtiger H, Wieland E, Armstrong VW, Shipkova M. The acyl glucuronide metabolite of mycophenolic acid induces tubulin polymerization in vitro. Clin Biochem. 2010 Jan;43(1-2):208-13. doi: 10.1016/j.clinbiochem.2009.08.023. Epub 2009 Sep 8.
PMID: 19744471
citation: Calmet FH, Yarur AJ, Pukazhendhi G, Ahmad J, Bhamidimarri KR. Endoscopic and histological features of mycophenolate mofetil colitis in patients after solid organ transplantation. Ann Gastroenterol. 2015 Jul-Sep;28(3):366-373.
PMID: 26126799
citation: Liapis G, Boletis J, Skalioti C, Bamias G, Tsimaratou K, Patsouris E, Delladetsima I. Histological spectrum of mycophenolate mofetil-related colitis: association with apoptosis. Histopathology. 2013 Nov;63(5):649-58. doi: 10.1111/his.12222. Epub 2013 Sep 11.
PMID: 24025088
citation: Sydora MJ, Sydora BC, Fedorak RN. Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome. J Crohns Colitis. 2012 Mar;6(2):207-14. doi: 10.1016/j.crohns.2011.08.008. Epub 2011 Sep 7.
PMID: 22325175
citation: Ferreiro-Iglesias R, Barreiro-de Acosta M, Lorenzo-Gonzalez A, Dominguez-Munoz JE. Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab. Scand J Gastroenterol. 2016;51(4):442-7. doi: 10.3109/00365521.2015.1115546. Epub 2015 Nov 23.
PMID: 26595391
citation: Lorenz F, Marklund S, Werner M, Palmqvist R, Wahlin BE, Wahlin A. Fecal calprotectin as a biomarker of intestinal graft versus host disease after allogeneic hematopoietic stem cell transplantation. Sci Rep. 2015 Jan 21;5:7920. doi: 10.1038/srep07920.
PMID: 25605402
citation: Konikoff MR, Denson LA. Role of fecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Jun;12(6):524-34. doi: 10.1097/00054725-200606000-00013.
PMID: 16775498
responsible party type: Sponsor
mesh term: Diarrhea
mesh term: Octreotide
sharing ipd: No