<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/NCT03015467</url>
  </required_header>
  <id_info>
    <org_study_id>AM-FMT-SAP</org_study_id>
    <nct_id>NCT03015467</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)</brief_title>
  <official_title>Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Chengdu Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Chengdu Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most&#xD;
      patients with severe pancreatitis associated with intestinal mucosal barrier&#xD;
      dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play&#xD;
      an important role in the development process in the course of severe acute pancreatitis. At&#xD;
      this stage of the study that infection of pancreas and other organs is the leading cause of&#xD;
      death in patients with severe acute pancreatitis，and the main pathogens from intestinal&#xD;
      micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota&#xD;
      Transplantation that has been used for treatment of inflammatory bowel disease and&#xD;
      Clostridium difficile infection may be a new technology for regulation of intestinal mucosal&#xD;
      dysfunction and intestinal flora unbalance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all&#xD;
      of them also will be separated into two parts depending on acceptation or refusal of FMT.&#xD;
      Blood specimens from patients will be collected to analysis inflammatory factors，and fecal&#xD;
      microbiota samples will be detection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein（CRP）</measure>
    <time_frame>2-4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diamine oxidase（DAO）</measure>
    <time_frame>2-4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin</measure>
    <time_frame>2-4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tumor necrosis factor-a(TNF-a)</measure>
    <time_frame>2-4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Acute Pancreatitis</condition>
  <condition>Intestinal Bacteria Flora Disturbance</condition>
  <condition>Intestinal Dysfunction</condition>
  <condition>Fecal Microbiota Transplantation</condition>
  <arm_group>
    <arm_group_label>treatment for part 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for part 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fecal Microbiota Transplantation</intervention_name>
    <description>Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1</description>
    <arm_group_label>treatment for part 1</arm_group_label>
    <other_name>Fecal Microbiota Transplantation (FMT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2</description>
    <arm_group_label>Placebo for part 2</arm_group_label>
    <other_name>normal saline (NS)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more&#xD;
             than 3-fold the upper reference limit) and evidence of pancreatitis on computed&#xD;
             tomography (CT) of the abdomen;&#xD;
&#xD;
          2. No chronic diseases of the digestive system ;&#xD;
&#xD;
          3. No chronic diseases of the urinary system;&#xD;
&#xD;
          4. No chronic metabolic disease;&#xD;
&#xD;
          5. No chronic disease of immune system&#xD;
&#xD;
          6. No chronic disease of mental disease&#xD;
&#xD;
          7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of&#xD;
             probiotics for one month;&#xD;
&#xD;
          8. No use of addictive drugs and immune inhibitors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. not to match the standard of AP&#xD;
&#xD;
          2. with chronic diseases of the digestive system;&#xD;
&#xD;
          3. with chronic diseases of the urinary system;&#xD;
&#xD;
          4. with chronic metabolic disease;&#xD;
&#xD;
          5. with chronic disease of immune system&#xD;
&#xD;
          6. with chronic disease of mental disease&#xD;
&#xD;
          7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history&#xD;
             of probiotics for one month;pregnancy and lactation women&#xD;
&#xD;
          8. with use of addictive drugs and immune inhibitors&#xD;
&#xD;
          9. exceed the age limits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Fang, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital of Chengdu Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Fang, Ph.D</last_name>
    <phone>+8613458555780</phone>
    <email>fangzjt@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yan Zhou, Ph.D</last_name>
    <phone>+8618981941992</phone>
    <email>269000947@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IEC of Chengdu Medical College</name>
      <address>
        <city>Chendu</city>
        <zip>610500</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao-an Li, post doctor</last_name>
      <phone>+8613680868858</phone>
      <email>zqzy1983@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Noor MT, Radhakrishna Y, Kochhar R, Ray P, Wig JD, Sinha SK, Singh K. Bacteriology of infection in severe acute pancreatitis. JOP. 2011 Jan 5;12(1):19-25.</citation>
    <PMID>21206096</PMID>
  </reference>
  <reference>
    <citation>Murphy SF, Rhee L, Grimm WA, Weber CR, Messer JS, Lodolce JP, Chang JE, Bartulis SJ, Nero T, Kukla RA, MacDougall G, Binghay C, Kolodziej LE, Boone DL. Intestinal epithelial expression of TNFAIP3 results in microbial invasion of the inner mucus layer and induces colitis in IL-10-deficient mice. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 1;307(9):G871-82. doi: 10.1152/ajpgi.00020.2014. Epub 2014 Sep 18.</citation>
    <PMID>25234043</PMID>
  </reference>
  <reference>
    <citation>Wu LM, Sankaran SJ, Plank LD, Windsor JA, Petrov MS. Meta-analysis of gut barrier dysfunction in patients with acute pancreatitis. Br J Surg. 2014 Dec;101(13):1644-56. doi: 10.1002/bjs.9665. Epub 2014 Oct 21.</citation>
    <PMID>25334028</PMID>
  </reference>
  <reference>
    <citation>Fishman JE, Levy G, Alli V, Zheng X, Mole DJ, Deitch EA. The intestinal mucus layer is a critical component of the gut barrier that is damaged during acute pancreatitis. Shock. 2014 Sep;42(3):264-70. doi: 10.1097/SHK.0000000000000209.</citation>
    <PMID>24978882</PMID>
  </reference>
  <reference>
    <citation>Schwender BJ, Gordon SR, Gardner TB. Risk factors for the development of intra-abdominal fungal infections in acute pancreatitis. Pancreas. 2015 Jul;44(5):805-7. doi: 10.1097/MPA.0000000000000334.</citation>
    <PMID>25872170</PMID>
  </reference>
  <reference>
    <citation>Hall JC, Crawford HC. The conspiracy of autophagy, stress and inflammation in acute pancreatitis. Curr Opin Gastroenterol. 2014 Sep;30(5):495-9. doi: 10.1097/MOG.0000000000000097.</citation>
    <PMID>25003605</PMID>
  </reference>
  <reference>
    <citation>Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MO, Kilic A, Gunal A, Kozak O. The Effects of Total Colectomy on Bacterial Translocation in a Model of Acute Pancreatitis. Indian J Surg. 2015 Dec;77(Suppl 2):412-8. doi: 10.1007/s12262-013-0855-y. Epub 2013 Jan 31.</citation>
    <PMID>26730036</PMID>
  </reference>
  <reference>
    <citation>Bongaerts GP, Severijnen RS. A reassessment of the PROPATRIA study and its implications for probiotic therapy. Nat Biotechnol. 2016 Jan;34(1):55-63. doi: 10.1038/nbt.3436.</citation>
    <PMID>26744983</PMID>
  </reference>
  <reference>
    <citation>Hansson GC, Johansson ME. The inner of the two Muc2 mucin-dependent mucus layers in colon is devoid of bacteria. Gut Microbes. 2010 Jan;1(1):51-54. doi: 10.4161/gmic.1.1.10470.</citation>
    <PMID>21327117</PMID>
  </reference>
  <reference>
    <citation>Zhang XP, Zhang J, Song QL, Chen HQ. Mechanism of acute pancreatitis complicated with injury of intestinal mucosa barrier. J Zhejiang Univ Sci B. 2007 Dec;8(12):888-95. doi: 10.1631/jzus.2007.B0888.</citation>
    <PMID>18257123</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute pancreatitis</keyword>
  <keyword>intestinal mucosal barrier</keyword>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</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/NCT03015467
org study id: AM-FMT-SAP
nct id: NCT03015467
lead sponsor: 
has dmc: Yes
Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most
      patients with severe pancreatitis associated with intestinal mucosal barrier
      dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play
      an important role in the development process in the course of severe acute pancreatitis. At
      this stage of the study that infection of pancreas and other organs is the leading cause of
      death in patients with severe acute pancreatitis，and the main pathogens from intestinal
      micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota
      Transplantation that has been used for treatment of inflammatory bowel disease and
      Clostridium difficile infection may be a new technology for regulation of intestinal mucosal
      dysfunction and intestinal flora unbalance.
Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all
      of them also will be separated into two parts depending on acceptation or refusal of FMT.
      Blood specimens from patients will be collected to analysis inflammatory factors，and fecal
      microbiota samples will be detection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality
time frame: 3 months
measure: C-reactive protein（CRP）
time frame: 2-4 weeks
measure: Diamine oxidase（DAO）
time frame: 2-4 weeks
measure: Interleukin
time frame: 2-4 weeks
measure: tumor necrosis factor-a(TNF-a)
time frame: 2-4 weeks
arm group label: treatment for part 1
arm group type: Active Comparator
description: Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1.
arm group label: Placebo for part 2
arm group type: Placebo Comparator
description: The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2.
intervention type: Other
intervention name: Fecal Microbiota Transplantation
description: Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1
arm group label: treatment for part 1
other name: Fecal Microbiota Transplantation (FMT)
intervention type: Other
intervention name: normal saline
description: normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2
arm group label: Placebo for part 2
other name: normal saline (NS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li Fang, Ph.D
role: Study Chair
affiliation: First Affiliated Hospital of Chengdu Medical College
last name: Li Fang, Ph.D
phone: +8613458555780
email: fangzjt@163.com
last name: Yan Zhou, Ph.D
phone: +8618981941992
email: 269000947@qq.com
facility: 
status: Recruiting
contact: 
country: China
citation: Noor MT, Radhakrishna Y, Kochhar R, Ray P, Wig JD, Sinha SK, Singh K. Bacteriology of infection in severe acute pancreatitis. JOP. 2011 Jan 5;12(1):19-25.
PMID: 21206096
citation: Murphy SF, Rhee L, Grimm WA, Weber CR, Messer JS, Lodolce JP, Chang JE, Bartulis SJ, Nero T, Kukla RA, MacDougall G, Binghay C, Kolodziej LE, Boone DL. Intestinal epithelial expression of TNFAIP3 results in microbial invasion of the inner mucus layer and induces colitis in IL-10-deficient mice. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 1;307(9):G871-82. doi: 10.1152/ajpgi.00020.2014. Epub 2014 Sep 18.
PMID: 25234043
citation: Wu LM, Sankaran SJ, Plank LD, Windsor JA, Petrov MS. Meta-analysis of gut barrier dysfunction in patients with acute pancreatitis. Br J Surg. 2014 Dec;101(13):1644-56. doi: 10.1002/bjs.9665. Epub 2014 Oct 21.
PMID: 25334028
citation: Fishman JE, Levy G, Alli V, Zheng X, Mole DJ, Deitch EA. The intestinal mucus layer is a critical component of the gut barrier that is damaged during acute pancreatitis. Shock. 2014 Sep;42(3):264-70. doi: 10.1097/SHK.0000000000000209.
PMID: 24978882
citation: Schwender BJ, Gordon SR, Gardner TB. Risk factors for the development of intra-abdominal fungal infections in acute pancreatitis. Pancreas. 2015 Jul;44(5):805-7. doi: 10.1097/MPA.0000000000000334.
PMID: 25872170
citation: Hall JC, Crawford HC. The conspiracy of autophagy, stress and inflammation in acute pancreatitis. Curr Opin Gastroenterol. 2014 Sep;30(5):495-9. doi: 10.1097/MOG.0000000000000097.
PMID: 25003605
citation: Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MO, Kilic A, Gunal A, Kozak O. The Effects of Total Colectomy on Bacterial Translocation in a Model of Acute Pancreatitis. Indian J Surg. 2015 Dec;77(Suppl 2):412-8. doi: 10.1007/s12262-013-0855-y. Epub 2013 Jan 31.
PMID: 26730036
citation: Bongaerts GP, Severijnen RS. A reassessment of the PROPATRIA study and its implications for probiotic therapy. Nat Biotechnol. 2016 Jan;34(1):55-63. doi: 10.1038/nbt.3436.
PMID: 26744983
citation: Hansson GC, Johansson ME. The inner of the two Muc2 mucin-dependent mucus layers in colon is devoid of bacteria. Gut Microbes. 2010 Jan;1(1):51-54. doi: 10.4161/gmic.1.1.10470.
PMID: 21327117
citation: Zhang XP, Zhang J, Song QL, Chen HQ. Mechanism of acute pancreatitis complicated with injury of intestinal mucosa barrier. J Zhejiang Univ Sci B. 2007 Dec;8(12):888-95. doi: 10.1631/jzus.2007.B0888.
PMID: 18257123
responsible party type: Sponsor
mesh term: Pancreatitis
sharing ipd: No