<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/NCT03806959</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A03229-44</org_study_id>
    <nct_id>NCT03806959</nct_id>
  </id_info>
  <brief_title>Interest of Pan-capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy</brief_title>
  <acronym>IPSILON</acronym>
  <official_title>Interest of Pan Capsule (Small Bowel and Colon Video Capsule) in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy. Phase A. Feasibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Avicenne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Adeprina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Avicenne</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>
      Irritable bowel syndrome (IBS) is a chronic disease characterized by the association of&#xD;
      abdominal pain and transit disorders. IBS affects 5 to 10% of the population. There are&#xD;
      several forms of IBS: IBS-D (with predominant diarrhea), IBS-C (with constipation&#xD;
      predominant) and IBS-M (mixed with alternating diarrhea and constipation). In the absence of&#xD;
      a diagnostic test to confirm the existence of this syndrome, the diagnosis of IBS is based on&#xD;
      clinical criteria (Rome IV criteria). In patients suspected of IBS, especially in patients&#xD;
      with diarrhea (IBS-D or IBS-M), a colonoscopy with biopsies is often proposed in addition to&#xD;
      biological tests (Complete Blood Count, C-reactive protein, thyroid stimulating hormon and&#xD;
      anti-transglutaminase antibodies) by the physician or gastroenterologist to exclude an&#xD;
      organic digestive disease such as celiac disease, IBD (Crohn's disease or ulcerative&#xD;
      colitis), microscopic colitis or even neoplasia.&#xD;
&#xD;
      The colonoscopy is an invasive exploration and does not allow exploration of the entire small&#xD;
      bowel.&#xD;
&#xD;
      The development of capsules allowed the exploration of the small bowel more recently of the&#xD;
      colon. The new developed pan-capsule allows evaluation of both small bowel and colon.&#xD;
&#xD;
      The aim of this work is to evaluate in patients younger than 50 years, presenting suspicious&#xD;
      digestive symptoms of IBS with diarrhea, the interest of a strategy based on the pan-capsule&#xD;
      as an alternative to colonoscopy to eliminate a diagnosis of organic digestive disease&#xD;
      (celiac disease, IBD, neoplasia, ..).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 7, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>every patient will have both pan-capsule and colonoscopy. comparison intra-group between lesions found by the two examinations.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with digestive pathology and / or significant gastrointestinal lesion.</measure>
    <time_frame>1 month</time_frame>
    <description>Number of patients with digestive pathology and / or significant gastrointestinal lesion (mucosal atrophy, mucosal erythema or ulceration, inflammatory bowel disease, neoplasia: colon adenocarcinoma, polyps&gt; 5 mm, microscopic colitis).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).</measure>
    <time_frame>1 month</time_frame>
    <description>Index of acceptability (visual analogy scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability to complete the questionnaires (number of completed questionnaires).</measure>
    <time_frame>1 month</time_frame>
    <description>Number of completed questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Irritable Bowel Syndrome With Diarrhea</condition>
  <arm_group>
    <arm_group_label>Pan Capsule and colonoscopy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pan Capsule and colonoscopy in patients with IBS</intervention_name>
    <description>Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only Usual biological tests (CBC, CRP, TSH, anti-transglutaminase antibodies) and measurement of fecal calprotectin.</description>
    <arm_group_label>Pan Capsule and colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female: Age ≥ 18 years and ≤ 50 years&#xD;
&#xD;
          -  Patients with symptoms compatible with IBS-D or IBS-M according to the treating&#xD;
             physician.&#xD;
&#xD;
          -  Indication for colonoscopy according to the physician&#xD;
&#xD;
          -  Absence of prior colonoscopy&#xD;
&#xD;
          -  Patient affiliated to a social security Insurance&#xD;
&#xD;
          -  Signature of signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Functional or organic disorders of swallowing.&#xD;
&#xD;
          -  Dysphagia or suspicion of digestive stenosis.&#xD;
&#xD;
          -  Known Zenker Diverticule.&#xD;
&#xD;
          -  Major surgical history of the digestive tract (exclusion of appendectomy,&#xD;
             cholecystectomy, surgery of hemorrhoids).&#xD;
&#xD;
          -  Known illness that could explain digestive symptoms.&#xD;
&#xD;
          -  Symptoms suggestive of occlusion.&#xD;
&#xD;
          -  Alteration of the general state and / or dehydration.&#xD;
&#xD;
          -  Chronic uncontrolled disease.&#xD;
&#xD;
          -  Disorders of consciousness.&#xD;
&#xD;
          -  Uncontrolled heart disease: myocardial infarction in the last 6 months, anginal&#xD;
             disease status, NYHA grade III and above congestive heart failure, ventricular&#xD;
             tachycardia, ventricular fibrillation, severe heart block.&#xD;
&#xD;
          -  Patient with a pacemaker or other implantable electronic medical device.&#xD;
&#xD;
          -  Polyethylene glycol allergy.&#xD;
&#xD;
          -  Oral iron intake in the four days preceding the video capsule.&#xD;
&#xD;
          -  Pregnant or lactating woman, woman of childbearing age who has not performed a&#xD;
             pregnancy test, women and men of childbearing potential without effective&#xD;
             contraception.&#xD;
&#xD;
          -  Impossible follow up for psychological or geographical reasons.&#xD;
&#xD;
          -  Patient under safeguard of justice.&#xD;
&#xD;
          -  Patient under guardianship or curatorship.&#xD;
&#xD;
          -  Simultaneous participation in another clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert BENAMOUZIG, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert BENAMOUZIG, Professor</last_name>
    <phone>+33148955334</phone>
    <email>robert.benamouzig@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mourad BENALLAOUA, PhD</last_name>
    <phone>+33148955555</phone>
    <phone_ext>56534</phone_ext>
    <email>mourad.benallaoua@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de Recherche sur Volontaires (CRV), Hospital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <state>Ile-de-France</state>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Benamouzig, PU-PH</last_name>
      <phone>+33148955334</phone>
      <email>robert.benamouzig@aphp.frr</email>
    </contact>
    <contact_backup>
      <last_name>Mourad Benallaoua, PhD</last_name>
      <phone>+33148955555</phone>
      <phone_ext>56534</phone_ext>
      <email>mourad.benallaoua@aphp.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Robert Benamouzig</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Le Pluart D, Sabate JM, Bouchoucha M, Hercberg S, Benamouzig R, Julia C. Functional gastrointestinal disorders in 35,447 adults and their association with body mass index. Aliment Pharmacol Ther. 2015 Apr;41(8):758-67. doi: 10.1111/apt.13143. Epub 2015 Mar 1.</citation>
    <PMID>25728697</PMID>
  </reference>
  <reference>
    <citation>Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.</citation>
    <PMID>27144627</PMID>
  </reference>
  <reference>
    <citation>Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology. 2000 Sep;119(3):654-60. doi: 10.1053/gast.2000.16484.</citation>
    <PMID>10982758</PMID>
  </reference>
  <reference>
    <citation>Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.</citation>
    <PMID>25199904</PMID>
  </reference>
  <reference>
    <citation>Corsetti M, Van Oudenhove L, Tack J. The quest for biomarkers in IBS-where should it lead us? Neurogastroenterol Motil. 2014 Dec;26(12):1669-76. doi: 10.1111/nmo.12475.</citation>
    <PMID>25424580</PMID>
  </reference>
  <reference>
    <citation>Andresen V, Whorwell P, Fortea J, Auziere S. An exploration of the barriers to the confident diagnosis of irritable bowel syndrome: A survey among general practitioners, gastroenterologists and experts in five European countries. United European Gastroenterol J. 2015 Feb;3(1):39-52. doi: 10.1177/2050640614558344.</citation>
    <PMID>25653858</PMID>
  </reference>
  <reference>
    <citation>Quigley EM. Overlapping irritable bowel syndrome and inflammatory bowel disease: less to this than meets the eye? Therap Adv Gastroenterol. 2016 Mar;9(2):199-212. doi: 10.1177/1756283X15621230.</citation>
    <PMID>26929782</PMID>
  </reference>
  <reference>
    <citation>Spiller R, Camilleri M, Longstreth GF. Do the symptom-based, Rome criteria of irritable bowel syndrome lead to better diagnosis and treatment outcomes? Clin Gastroenterol Hepatol. 2010 Feb;8(2):125-9; discussion 129-36. doi: 10.1016/j.cgh.2009.12.018. No abstract available.</citation>
    <PMID>20152787</PMID>
  </reference>
  <reference>
    <citation>Lieberman DA, Holub J, Eisen G, Kraemer D, Morris CD. Utilization of colonoscopy in the United States: results from a national consortium. Gastrointest Endosc. 2005 Dec;62(6):875-83. doi: 10.1016/j.gie.2005.06.037.</citation>
    <PMID>16301030</PMID>
  </reference>
  <reference>
    <citation>Chey WD, Nojkov B, Rubenstein JH, Dobhan RR, Greenson JK, Cash BD. The yield of colonoscopy in patients with non-constipated irritable bowel syndrome: results from a prospective, controlled US trial. Am J Gastroenterol. 2010 Apr;105(4):859-65. doi: 10.1038/ajg.2010.55. Epub 2010 Feb 23.</citation>
    <PMID>20179696</PMID>
  </reference>
  <reference>
    <citation>Ishihara S, Yashima K, Kushiyama Y, Izumi A, Kawashima K, Fujishiro H, Kojo H, Komazawa Y, Hamamoto T, Yamamoto T, Sasaki Y, Shimizu T, Okamoto E, Yoshimura T, Furuta K, Noguchi N, Tanaka H, Murawaki Y, Kinoshita Y. Prevalence of organic colonic lesions in patients meeting Rome III criteria for diagnosis of IBS: a prospective multi-center study utilizing colonoscopy. J Gastroenterol. 2012 Oct;47(10):1084-90. doi: 10.1007/s00535-012-0573-4. Epub 2012 Mar 30.</citation>
    <PMID>22460220</PMID>
  </reference>
  <reference>
    <citation>Patel P, Bercik P, Morgan DG, Bolino C, Pintos-Sanchez MI, Moayyedi P, Ford AC. Prevalence of organic disease at colonoscopy in patients with symptoms compatible with irritable bowel syndrome: cross-sectional survey. Scand J Gastroenterol. 2015 Jul;50(7):816-23. doi: 10.3109/00365521.2015.1007079. Epub 2015 Jan 30.</citation>
    <PMID>25636675</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Avicenne</investigator_affiliation>
    <investigator_full_name>Robert Benamouzig</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <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/NCT03806959
org study id: 2017-A03229-44
nct id: NCT03806959
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Irritable bowel syndrome (IBS) is a chronic disease characterized by the association of
      abdominal pain and transit disorders. IBS affects 5 to 10% of the population. There are
      several forms of IBS: IBS-D (with predominant diarrhea), IBS-C (with constipation
      predominant) and IBS-M (mixed with alternating diarrhea and constipation). In the absence of
      a diagnostic test to confirm the existence of this syndrome, the diagnosis of IBS is based on
      clinical criteria (Rome IV criteria). In patients suspected of IBS, especially in patients
      with diarrhea (IBS-D or IBS-M), a colonoscopy with biopsies is often proposed in addition to
      biological tests (Complete Blood Count, C-reactive protein, thyroid stimulating hormon and
      anti-transglutaminase antibodies) by the physician or gastroenterologist to exclude an
      organic digestive disease such as celiac disease, IBD (Crohn's disease or ulcerative
      colitis), microscopic colitis or even neoplasia.

      The colonoscopy is an invasive exploration and does not allow exploration of the entire small
      bowel.

      The development of capsules allowed the exploration of the small bowel more recently of the
      colon. The new developed pan-capsule allows evaluation of both small bowel and colon.

      The aim of this work is to evaluate in patients younger than 50 years, presenting suspicious
      digestive symptoms of IBS with diarrhea, the interest of a strategy based on the pan-capsule
      as an alternative to colonoscopy to eliminate a diagnosis of organic digestive disease
      (celiac disease, IBD, neoplasia, ..).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: every patient will have both pan-capsule and colonoscopy. comparison intra-group between lesions found by the two examinations.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients with digestive pathology and / or significant gastrointestinal lesion.
time frame: 1 month
description: Number of patients with digestive pathology and / or significant gastrointestinal lesion (mucosal atrophy, mucosal erythema or ulceration, inflammatory bowel disease, neoplasia: colon adenocarcinoma, polyps> 5 mm, microscopic colitis).
measure: Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).
time frame: 1 month
description: Index of acceptability (visual analogy scale)
measure: Acceptability to complete the questionnaires (number of completed questionnaires).
time frame: 1 month
description: Number of completed questionnaire
arm group label: Pan Capsule and colonoscopy
arm group type: Other
description: Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only
intervention type: Other
intervention name: Pan Capsule and colonoscopy in patients with IBS
description: Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only Usual biological tests (CBC, CRP, TSH, anti-transglutaminase antibodies) and measurement of fecal calprotectin.
arm group label: Pan Capsule and colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Robert BENAMOUZIG, Professor
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Robert BENAMOUZIG, Professor
phone: +33148955334
email: robert.benamouzig@aphp.fr
last name: Mourad BENALLAOUA, PhD
phone: +33148955555
phone ext: 56534
email: mourad.benallaoua@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
citation: Le Pluart D, Sabate JM, Bouchoucha M, Hercberg S, Benamouzig R, Julia C. Functional gastrointestinal disorders in 35,447 adults and their association with body mass index. Aliment Pharmacol Ther. 2015 Apr;41(8):758-67. doi: 10.1111/apt.13143. Epub 2015 Mar 1.
PMID: 25728697
citation: Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.
PMID: 27144627
citation: Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EA. The impact of irritable bowel syndrome on health-related quality of life. Gastroenterology. 2000 Sep;119(3):654-60. doi: 10.1053/gast.2000.16484.
PMID: 10982758
citation: Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.
PMID: 25199904
citation: Corsetti M, Van Oudenhove L, Tack J. The quest for biomarkers in IBS-where should it lead us? Neurogastroenterol Motil. 2014 Dec;26(12):1669-76. doi: 10.1111/nmo.12475.
PMID: 25424580
citation: Andresen V, Whorwell P, Fortea J, Auziere S. An exploration of the barriers to the confident diagnosis of irritable bowel syndrome: A survey among general practitioners, gastroenterologists and experts in five European countries. United European Gastroenterol J. 2015 Feb;3(1):39-52. doi: 10.1177/2050640614558344.
PMID: 25653858
citation: Quigley EM. Overlapping irritable bowel syndrome and inflammatory bowel disease: less to this than meets the eye? Therap Adv Gastroenterol. 2016 Mar;9(2):199-212. doi: 10.1177/1756283X15621230.
PMID: 26929782
citation: Spiller R, Camilleri M, Longstreth GF. Do the symptom-based, Rome criteria of irritable bowel syndrome lead to better diagnosis and treatment outcomes? Clin Gastroenterol Hepatol. 2010 Feb;8(2):125-9; discussion 129-36. doi: 10.1016/j.cgh.2009.12.018. No abstract available.
PMID: 20152787
citation: Lieberman DA, Holub J, Eisen G, Kraemer D, Morris CD. Utilization of colonoscopy in the United States: results from a national consortium. Gastrointest Endosc. 2005 Dec;62(6):875-83. doi: 10.1016/j.gie.2005.06.037.
PMID: 16301030
citation: Chey WD, Nojkov B, Rubenstein JH, Dobhan RR, Greenson JK, Cash BD. The yield of colonoscopy in patients with non-constipated irritable bowel syndrome: results from a prospective, controlled US trial. Am J Gastroenterol. 2010 Apr;105(4):859-65. doi: 10.1038/ajg.2010.55. Epub 2010 Feb 23.
PMID: 20179696
citation: Ishihara S, Yashima K, Kushiyama Y, Izumi A, Kawashima K, Fujishiro H, Kojo H, Komazawa Y, Hamamoto T, Yamamoto T, Sasaki Y, Shimizu T, Okamoto E, Yoshimura T, Furuta K, Noguchi N, Tanaka H, Murawaki Y, Kinoshita Y. Prevalence of organic colonic lesions in patients meeting Rome III criteria for diagnosis of IBS: a prospective multi-center study utilizing colonoscopy. J Gastroenterol. 2012 Oct;47(10):1084-90. doi: 10.1007/s00535-012-0573-4. Epub 2012 Mar 30.
PMID: 22460220
citation: Patel P, Bercik P, Morgan DG, Bolino C, Pintos-Sanchez MI, Moayyedi P, Ford AC. Prevalence of organic disease at colonoscopy in patients with symptoms compatible with irritable bowel syndrome: cross-sectional survey. Scand J Gastroenterol. 2015 Jul;50(7):816-23. doi: 10.3109/00365521.2015.1007079. Epub 2015 Jan 30.
PMID: 25636675
responsible party type: Principal Investigator
investigator affiliation: Hospital Avicenne
investigator full name: Robert Benamouzig
investigator title: Professor, MD, PhD
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Diarrhea
sharing ipd: No