Crohn's DiseaseNCT02502552
Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort
An observational study of Crohn's Disease and Ulcerative Colitis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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…). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease
- What is being tested?
- blood specimen
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ulcerative colitis and Crohn's disease patient followed in Saint-Etienne Hospital since 3 years or more
Who may be able to join
- Patients included in previous study (AOL 2010) and followed in our department, accepting blood sampling and stool analysis
- Written consent of the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort - A Monocentric Study
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.
Read the 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.
- Being tested
- blood specimen
- Keywords
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease, anti-glycan antibodies, antibodies stability, mucosal healing, predictive markers
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood specimenOther
blood specimen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: blood specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunological status
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.
Measured: 3 years after first evaluation
Secondary outcomes (5)
clinical remission
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
Measured: 3 years after first evaluation
anti-Tumor Necrosis Factor (TNF) therapeutic response
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
Measured: 3 years after first evaluation
Mucosal healing
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
Measured: 3 years after first evaluation
Intestinal permeability
Comparison of intestinal permeability between patients with a change in their immunological status and patients with stable status.
- 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.
Measured: 3 years after first evaluation
surgical resection
Comparison of number of surgical resection between patients with a change in their immunological status and patients with stable status.
- Surgical resection may be a colonic or small bowel resection surgery for CD patients or colectomy for UC patients.
Measured: 3 years after first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Roblin, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502552
- Sponsor's protocol ID
- 1308018
- Status last verified
- Oct 2015
- First submitted
- 16 Jul 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort - A Monocentric Study
- ClinicalTrials.gov ID
- NCT02502552
- Acronym / sponsor ID
- 1308018
- Keywords
- Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease, anti-glycan antibodies, antibodies stability, mucosal healing, predictive markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | Other: blood specimenInflammatory Bowel Disease patients followed in Saint-Etienne Hospital since 3 years or more. Blood specimen 3 years after a first blood specimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ulcerative colitis and Crohn's disease patient followed in Saint-Etienne Hospital since 3 years or more
Key inclusion criteria (2 listed)
- Patients included in previous study (AOL 2010) and followed in our department, accepting blood sampling and stool analysis
- Written consent of the patient
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood specimenblood specimen | Other | Inflammatory Bowel Disease |
Primary outcome
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.
5 secondary outcomes
clinical remission
Time frame: 3 years after first evaluation
anti-Tumor Necrosis Factor (TNF) therapeutic response
Time frame: 3 years after first evaluation
Mucosal healing
Time frame: 3 years after first evaluation
Intestinal permeability
Time frame: 3 years after first evaluation
surgical resection
Time frame: 3 years after first evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Roblin, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunological status (time frame: 3 years after first evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.