Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort
|ClinicalTrials.gov Identifier: NCT02502552|
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment|
|Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease||Other: blood specimen|
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|
|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|
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
- 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.
- 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:
- Crohn's disease activity index (CDAI) score is lower than 150 for Crohn's disease
- Lichtiger score is < 4 for Ulcerative Colitis
- 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
- 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:
- C-reactive Protein (CRP) < 5mg/L and fecal calprotectin <250 µg/g
- Fecal calprotectin <150 µg/g in Ulcerative colitis
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502552
|Saint-Etienne, France, 42055|
|Principal Investigator:||Xavier Roblin, PhD||CHU Saint-Etienne|