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Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort

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ClinicalTrials.gov Identifier: NCT02502552
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.

Condition or disease Intervention/treatment
Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease Other: blood specimen

Detailed Description:

There is few data on the stability of these antibodies, most of the studies are cross-sectional. There are conflicting results among scarce longitudinal data. One study reported a negativation of anti-glycan antibodies in some cases but not of ASCA or ANCA.

On the cohort of 195 patients included in the first study, the investigator would like to assess at 3 years the immunological profiles of these patients and thus to compare them. In case of modification of the serological status for some antibodies, the search for associated factors (clinical, biological or therapeutic) will be performed. In case of sero-negativation of anti-glycan antibodies, this could be linked with a decrease or a normalization of the increased intestinal permeability in IBD. Indeed, in this subgroup of patients, we will test this hypothesis by analyzing intestinal permeability in anti-glycan positive group on the 2 samples and in the group with a sero-negativation on the second sample.


Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort - A Monocentric Study
Study Start Date : November 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Inflammatory Bowel Disease
Inflammatory Bowel Disease patients followed in Saint-Etienne Hospital since 3 years or more. Blood specimen 3 years after a first blood specimen
Other: blood specimen
blood specimen




Primary Outcome Measures :
  1. immunological status [ Time Frame: 3 years after first evaluation ]

    Immunological status is defined by anti-glycan antibodies (ACCA, ALCA, AMCA, anti-chitin and anti-laminarin), ASCA and ANCA.

    Antibody will be positive if level is found higher than the threshold defined by the laboratory (technical threshold).

    An antibody will be defined as stable if its status remains positive during 3 years(above the detection limit given by the reference laboratory) or negative during 3 years (below the detection limit given by the reference laboratory). Conversely, the lack of stability during 3 years will be defined as the transition from a positive to a negative status or inversely.



Secondary Outcome Measures :
  1. clinical remission [ Time Frame: 3 years after first evaluation ]

    Comparison of clinical remission between patients with a change in their immunological status and patients with stable status.

    A patient is in clinical remission if:

    1. Crohn's disease activity index (CDAI) score is lower than 150 for Crohn's disease
    2. Lichtiger score is < 4 for Ulcerative Colitis

  2. anti-Tumor Necrosis Factor (TNF) therapeutic response [ Time Frame: 3 years after first evaluation ]

    Comparison of anti-TNF (Tumor Necrosis Factor) therapeutic response between patients with a change in their immunological status and patients with stable status.

    A patient is considered as anti-TNF responder if there is a clinical remission without therapeutic change in the medical history of the patient


  3. Mucosal healing [ Time Frame: 3 years after first evaluation ]

    Comparison of mucosal healing between patients with a change in their immunological status and patients with stable status.

    A patient will be considered in mucosal healing if:

    1. C-reactive Protein (CRP) < 5mg/L and fecal calprotectin <250 µg/g
    2. Fecal calprotectin <150 µg/g in Ulcerative colitis

  4. Intestinal permeability [ Time Frame: 3 years after first evaluation ]

    Comparison of intestinal permeability between patients with a change in their immunological status and patients with stable status.

    4. Normalization of intestinal permeability will be defined if lipopolysaccharide (LPS) or anti-LPS Antibodies (IgG) level measured by LAL or ELISA is significantly reduced between the two samples. As there is no pre-defined threshold for LPS and anti-LPS Antibodies level in normalization of intestinal permeability, we will calculate a delta (level before - level at 3 years) for each patient and each parameter. We will analyze the average delta with the stability or not of immunological status.


  5. surgical resection [ Time Frame: 3 years after first evaluation ]

    Comparison of number of surgical resection between patients with a change in their immunological status and patients with stable status.

    5. Surgical resection may be a colonic or small bowel resection surgery for CD patients or colectomy for UC patients.



Biospecimen Retention:   Samples Without DNA
blood specimen in IBD cohort of 195 patients followed in Saint-Etienne Hospital


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Ulcerative colitis and Crohn's disease patient followed in Saint-Etienne Hospital since 3 years or more
Criteria

Inclusion Criteria:

  • Patients included in previous study (AOL 2010) and followed in our department, accepting blood sampling and stool analysis
  • Written consent of the patient

Exclusion Criteria:

  • Patient who decline to participate to the study
  • Patient in the incapacity to give consent
  • Patient deprived of their liberty by a judicial or administrative decision

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 ClinicalTrials.gov identifier (NCT number): NCT02502552


Locations
France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Xavier Roblin, PhD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02502552     History of Changes
Other Study ID Numbers: 1308018
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
anti-glycan antibodies
antibodies stability
mucosal healing
predictive markers

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs