<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/NCT03266068</url>
  </required_header>
  <id_info>
    <org_study_id>12-006529</org_study_id>
    <secondary_id>K23DK103911</secondary_id>
    <secondary_id>P30DK084567</secondary_id>
    <secondary_id>UL1TR000135</secondary_id>
    <nct_id>NCT03266068</nct_id>
  </id_info>
  <brief_title>Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders</brief_title>
  <official_title>Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      Some people develop chronic abdominal pain with diarrhea or constipation after an episode of&#xD;
      acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious&#xD;
      irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact&#xD;
      reason why certain individuals develop these symptoms whereas others don't is not exactly&#xD;
      clear.&#xD;
&#xD;
      The researchers are studying changes in gastrointestinal permeability (movement of contents&#xD;
      across the lining of the intestine) and transit (movement of food through the&#xD;
      gastrointestinal tract). The researchers are also studying if there are any genetic risk&#xD;
      factors that are associated with development of this disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Centers for Disease Control and prevention (CDC) estimates that each year roughly 1 in 6&#xD;
      Americans (or 48 million people) contact food-borne illnesses. The CDC also estimates that&#xD;
      between 20 and 40% of individuals traveling to a developing country get traveler's diarrhea.&#xD;
      There is morbidity from these illnesses, even after the acute episode is over. Thus, up to a&#xD;
      third of patients suffering from acute infectious gastroenteritis (IGE), most often resulting&#xD;
      from a food-borne outbreak or travel develop chronic gastrointestinal (GI) illnesses such as&#xD;
      irritable bowel syndrome (IBS). In addition, recent studies are suggesting that military&#xD;
      personnel who suffered from IGE during deployment are more likely to suffer from IBS&#xD;
      post-deployment. This disorder has been described as post-infectious IBS (PI-IBS).&#xD;
&#xD;
      Individuals with PI-IBS suffer from recurrent, debilitating abdominal pain and altered bowel&#xD;
      function (diarrhea and/or constipation) and symptoms can be present for over 8 years after&#xD;
      the acute IGE episode is over. It is estimated that up to 15% of the United States population&#xD;
      suffers from IBS. This disorder creates significant impact on patient's daily functioning,&#xD;
      overall quality of life and causes loss of work productivity. Despite the impact of this&#xD;
      illness, treatment options for IBS have limited success, with a significant unmet need. Lack&#xD;
      of understanding of underlying pathophysiological mechanisms has hampered development of&#xD;
      effective treatment. More studies are required to enhance understanding of this disorder.&#xD;
      Development of PI-IBS after an episode of acute IGE serves as a unique model to study&#xD;
      risk-factors and mechanisms underlying PI-IBS and IBS in general. The researchers propose to&#xD;
      study the epidemiological risk factors and pathophysiological mechanisms involved in the&#xD;
      development of IBS among individuals suffering from episodes of acute IGE in the community.&#xD;
&#xD;
      Pathophysiology of IBS includes abnormalities of GI motility, sensation, mucosal defense,&#xD;
      immune function and psychosocial factors. The researchers propose to investigate overall risk&#xD;
      and patient demographic, pathogen and illness related characteristics as predictors for&#xD;
      development of PI-IBS among patients who had suffered from acute IGE. In addition, the&#xD;
      researchers want to determine pathophysiological mechanisms leading to the development of&#xD;
      this disorder.&#xD;
&#xD;
      In order to achieve these goals, the researchers propose to establish collaboration with the&#xD;
      Minnesota Department of Health (MDH) which conducts active surveillance for bacterial and&#xD;
      parasitic cases of acute IGE and other reportable illnesses in Minnesota, as part of the&#xD;
      mandate to detecting outbreaks and prioritize control efforts. We plan to establish&#xD;
      retrospective and prospective cohorts in this proposal. A randomly selected sub-set of these&#xD;
      patients will be invited to Mayo Clinic for detailed investigations including assessment of&#xD;
      GI motility, permeability, endoscopic examination for colon biopsies, and diverse blood and&#xD;
      stool assays using techniques that are all validated to provide information about the&#xD;
      mechanism of PI-IBS. The researchers will also investigate variations in the barrier function&#xD;
      pathway genes in tissues of PI-IBS patients and to understand the contribution of these&#xD;
      genetic variations in immune activation and control of barrier function to increased&#xD;
      susceptibility to PI-IBS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Colonic geometric center at 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Campylobacter Infections</condition>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Post Infectious IBS Case</arm_group_label>
    <description>Subjects who have suffered from acute bacterial gastroenteritis within last two years and have developed some symptoms that might be suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post Infectious with no IBS Control</arm_group_label>
    <description>Subjects who have suffered from acute bacterial gastroenteritis within last two years and have not developed symptoms suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <description>Healthy volunteers; subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>DNA Analysis of Blood Sample</intervention_name>
    <description>DNA analysis of the genes possibly involved in IBS.</description>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Post Infectious IBS Case</arm_group_label>
    <arm_group_label>Post Infectious with no IBS Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flexible sigmoidoscopy with colonic biopsies</intervention_name>
    <description>Endoscopy of the subject's lower colon in which biopsies of the lining of the colon will be taken.</description>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Post Infectious IBS Case</arm_group_label>
    <arm_group_label>Post Infectious with no IBS Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Small bowel and colonic gastrointestinal permeability</intervention_name>
    <description>A validated scintigraphic method to measure gastric, small bowel and colonic transit will be used.</description>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Post Infectious IBS Case</arm_group_label>
    <arm_group_label>Post Infectious with no IBS Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Stool sample analysis</intervention_name>
    <description>Stool samples will be used to extract supernatants. These supernatants will be studied in using chamber set-up to determine barrier effects on T84 monolayers.</description>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Post Infectious IBS Case</arm_group_label>
    <arm_group_label>Post Infectious with no IBS Control</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, stool, and tissue samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Post Infectious IBS Cases Post Infectious with no IBS Controls Healthy Volunteer Controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Post Infectious IBS Cases Inclusion Criteria:&#xD;
&#xD;
          1. IBS by Rome III criteria&#xD;
&#xD;
          2. No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and&#xD;
             cholecystectomy)&#xD;
&#xD;
        Post Infectious with no IBS Controls Inclusion Criteria:&#xD;
&#xD;
          1. No IBS by Rome III criteria&#xD;
&#xD;
          2. No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and&#xD;
             cholecystectomy)&#xD;
&#xD;
        Post Infectious IBS Cases and Post Infectious with no IBS Controls Exclusion Criteria:&#xD;
&#xD;
          1. Prior history of IBS or inflammatory bowel disease (IBD) (Crohn's disease or&#xD;
             ulcerative colitis), microscopic colitis or celiac disease&#xD;
&#xD;
          2. Ingestion of artificial sweeteners such as sucralose, aspartame, lactulose or mannitol&#xD;
             2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints&#xD;
             and diet soda&#xD;
&#xD;
          3. Ingestion of any prescription, over the counter, or herbal medications which can&#xD;
             affect gastrointestinal transit 7 days before study begins&#xD;
&#xD;
               1. Any treatment specifically taken for IBS, including loperamide, cholestyramine,&#xD;
                  alosetron&#xD;
&#xD;
               2. Drugs with a known pharmacological activity at serotonin type 4 (5-HT4),&#xD;
                  serotonin receptor 2B (5-HT2b) or 5-HT3 receptors (e.g, tegaserod, ondansetron,&#xD;
                  tropisetron, granisetron, dolasetron, mirtazapine)&#xD;
&#xD;
               3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in&#xD;
                  combination)&#xD;
&#xD;
               4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)&#xD;
&#xD;
               5. Ultram&#xD;
&#xD;
               6. GI preparations&#xD;
&#xD;
                    -  Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine,&#xD;
                       dimenhydrinate, hydroxyzine)&#xD;
&#xD;
                    -  Osmotic laxative agents (e.g, lactulose, sorbitol or polyethylene glycol&#xD;
                       (PEG) solutions as Miralax and Glycolax)&#xD;
&#xD;
                    -  Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone)&#xD;
&#xD;
               7. Antimuscarinics&#xD;
&#xD;
               8. Peppermint oil&#xD;
&#xD;
               9. Systemic antibiotics, rifaximin, metronidazole&#xD;
&#xD;
          4. Any females who are pregnant or trying to become pregnant (due to radiation exposure)&#xD;
&#xD;
          5. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies&#xD;
&#xD;
        Healthy Control Inclusion Criteria:&#xD;
&#xD;
          1. No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and&#xD;
             cholecystectomy)&#xD;
&#xD;
          2. No history of acute gastroenteritis, food-poisoning or travel related diarrhea within&#xD;
             last 2 years.&#xD;
&#xD;
        Healthy Control Exclusion Criteria:&#xD;
&#xD;
          1. Prior history of IBS or IBD (Crohn's disease or ulcerative colitis), microscopic&#xD;
             colitis or celiac disease&#xD;
&#xD;
          2. Ingestion of artificial sweeteners such as sucralose, aspartame, lactulose or mannitol&#xD;
             2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints&#xD;
             and diet soda&#xD;
&#xD;
          3. Ingestion of any prescription, over the counter, or herbal medications which can&#xD;
             affect gastrointestinal transit 7 days before study begins&#xD;
&#xD;
               1. Any treatment specifically taken for IBS, including loperamide, cholestyramine,&#xD;
                  alosetron&#xD;
&#xD;
               2. Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors&#xD;
                  (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine)&#xD;
&#xD;
               3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in&#xD;
                  combination)&#xD;
&#xD;
               4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)&#xD;
&#xD;
               5. Ultram&#xD;
&#xD;
               6. GI preparations&#xD;
&#xD;
                    -  Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine,&#xD;
                       dimenhydrinate, hydroxyzine)&#xD;
&#xD;
                    -  Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as&#xD;
                       Miralax and Glycolax)&#xD;
&#xD;
                    -  Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone)&#xD;
&#xD;
               7. Antimuscarinics&#xD;
&#xD;
               8. Peppermint oil&#xD;
&#xD;
               9. Systemic antibiotics, rifaximin, metronidazole&#xD;
&#xD;
          4. Any females who are pregnant or trying to become pregnant (due to radiation exposure)&#xD;
&#xD;
          5. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Madhusudan Grover, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Madhusudan (Madhu) Grover, MBBS</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Campylobacter Infections</mesh_term>
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
  </condition_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/NCT03266068
org study id: 12-006529
secondary id: K23DK103911
secondary id: P30DK084567
secondary id: UL1TR000135
nct id: NCT03266068
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Some people develop chronic abdominal pain with diarrhea or constipation after an episode of
      acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious
      irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact
      reason why certain individuals develop these symptoms whereas others don't is not exactly
      clear.

      The researchers are studying changes in gastrointestinal permeability (movement of contents
      across the lining of the intestine) and transit (movement of food through the
      gastrointestinal tract). The researchers are also studying if there are any genetic risk
      factors that are associated with development of this disorder.
The Centers for Disease Control and prevention (CDC) estimates that each year roughly 1 in 6
      Americans (or 48 million people) contact food-borne illnesses. The CDC also estimates that
      between 20 and 40% of individuals traveling to a developing country get traveler's diarrhea.
      There is morbidity from these illnesses, even after the acute episode is over. Thus, up to a
      third of patients suffering from acute infectious gastroenteritis (IGE), most often resulting
      from a food-borne outbreak or travel develop chronic gastrointestinal (GI) illnesses such as
      irritable bowel syndrome (IBS). In addition, recent studies are suggesting that military
      personnel who suffered from IGE during deployment are more likely to suffer from IBS
      post-deployment. This disorder has been described as post-infectious IBS (PI-IBS).

      Individuals with PI-IBS suffer from recurrent, debilitating abdominal pain and altered bowel
      function (diarrhea and/or constipation) and symptoms can be present for over 8 years after
      the acute IGE episode is over. It is estimated that up to 15% of the United States population
      suffers from IBS. This disorder creates significant impact on patient's daily functioning,
      overall quality of life and causes loss of work productivity. Despite the impact of this
      illness, treatment options for IBS have limited success, with a significant unmet need. Lack
      of understanding of underlying pathophysiological mechanisms has hampered development of
      effective treatment. More studies are required to enhance understanding of this disorder.
      Development of PI-IBS after an episode of acute IGE serves as a unique model to study
      risk-factors and mechanisms underlying PI-IBS and IBS in general. The researchers propose to
      study the epidemiological risk factors and pathophysiological mechanisms involved in the
      development of IBS among individuals suffering from episodes of acute IGE in the community.

      Pathophysiology of IBS includes abnormalities of GI motility, sensation, mucosal defense,
      immune function and psychosocial factors. The researchers propose to investigate overall risk
      and patient demographic, pathogen and illness related characteristics as predictors for
      development of PI-IBS among patients who had suffered from acute IGE. In addition, the
      researchers want to determine pathophysiological mechanisms leading to the development of
      this disorder.

      In order to achieve these goals, the researchers propose to establish collaboration with the
      Minnesota Department of Health (MDH) which conducts active surveillance for bacterial and
      parasitic cases of acute IGE and other reportable illnesses in Minnesota, as part of the
      mandate to detecting outbreaks and prioritize control efforts. We plan to establish
      retrospective and prospective cohorts in this proposal. A randomly selected sub-set of these
      patients will be invited to Mayo Clinic for detailed investigations including assessment of
      GI motility, permeability, endoscopic examination for colon biopsies, and diverse blood and
      stool assays using techniques that are all validated to provide information about the
      mechanism of PI-IBS. The researchers will also investigate variations in the barrier function
      pathway genes in tissues of PI-IBS patients and to understand the contribution of these
      genetic variations in immune activation and control of barrier function to increased
      susceptibility to PI-IBS.
observational model: Case-Control
time perspective: Prospective
measure: Colonic geometric center at 24 hours
time frame: 24 hours
description: The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
arm group label: Post Infectious IBS Case
description: Subjects who have suffered from acute bacterial gastroenteritis within last two years and have developed some symptoms that might be suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.
arm group label: Post Infectious with no IBS Control
description: Subjects who have suffered from acute bacterial gastroenteritis within last two years and have not developed symptoms suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.
arm group label: Healthy Control
description: Healthy volunteers; subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.
intervention type: Genetic
intervention name: DNA Analysis of Blood Sample
description: DNA analysis of the genes possibly involved in IBS.
arm group label: Healthy Control
arm group label: Post Infectious IBS Case
arm group label: Post Infectious with no IBS Control
intervention type: Procedure
intervention name: Flexible sigmoidoscopy with colonic biopsies
description: Endoscopy of the subject's lower colon in which biopsies of the lining of the colon will be taken.
arm group label: Healthy Control
arm group label: Post Infectious IBS Case
arm group label: Post Infectious with no IBS Control
intervention type: Procedure
intervention name: Small bowel and colonic gastrointestinal permeability
description: A validated scintigraphic method to measure gastric, small bowel and colonic transit will be used.
arm group label: Healthy Control
arm group label: Post Infectious IBS Case
arm group label: Post Infectious with no IBS Control
intervention type: Diagnostic Test
intervention name: Stool sample analysis
description: Stool samples will be used to extract supernatants. These supernatants will be studied in using chamber set-up to determine barrier effects on T84 monolayers.
arm group label: Healthy Control
arm group label: Post Infectious IBS Case
arm group label: Post Infectious with no IBS Control
Blood, stool, and tissue samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Madhusudan Grover, MBBS
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Madhusudan (Madhu) Grover, MBBS
investigator title: Assistant Professor of Medicine
mesh term: Campylobacter Infections
mesh term: Irritable Bowel Syndrome