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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03809728
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
Interventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Procedure: endoscopic biopsy Procedure: samples of the oral cavity Procedure: Samples of the resected specimen Not Applicable

Detailed Description:

Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).

Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .

Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Estimated Study Start Date : April 2, 2019
Estimated Primary Completion Date : April 2, 2021
Estimated Study Completion Date : April 2, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
IBD patients
All patients with an established Crohn's disease or ulcerative colitis
Procedure: endoscopic biopsy
Per-endoscopic biopsies

Procedure: samples of the oral cavity
7 samples of the oral cavity with a swab

Procedure: Samples of the resected specimen
if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised

Primary Outcome Measures :
  1. Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Proportion of patients who underwent surgery [ Time Frame: 5 years ]
  2. Post-operative morbidity rates in IBD [ Time Frame: 5 years ]
  3. Surgical recurrent rate in Crohn's disease [ Time Frame: 5 years ]
  4. Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula) [ Time Frame: 5 years ]
  5. Proportion of patients developing a cancer [ Time Frame: 5 years ]
  6. Readmission rates for acute severe colitis or ileitis [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age>=18 years
  • Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
  • Patients >=45 kg
  • Affiliated member of the Social Security system

Exclusion Criteria:

  • Patients with an undetermined colitis
  • Patients with a non established diagnosis of CD
  • Women of childbearing age without a method of contraception
  • Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
  • Pregnant women, breastfeeding women

    -- Age < 18 years

  • Persons under legal protection
  • Person who does not have the capacity to consent
  • Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03809728

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Contact: Adeline GERMAIN, MD, PhD +33383153120

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CHRU Nancy Not yet recruiting
Vandœuvre-lès-Nancy, France, 54510
Contact: Marjorie STARCK    +33383155273   
Sub-Investigator: Laurent PEYRIN-BIROULET, MD, PhD         
Principal Investigator: Adeline GERMAIN, MD,PhD         
Sub-Investigator: Laurent BRESLER, MD         
Sub-Investigator: Camille ZALLOT, MD         
Sub-Investigator: Marine FERRY, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
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Principal Investigator: Adeline GERMAIN, MD, PhD CHRU Nancy

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Responsible Party: Central Hospital, Nancy, France Identifier: NCT03809728     History of Changes
Other Study ID Numbers: PSS 2018 / I-BANK-GERMAIN / MS
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases