Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease

Completed

• Conditions: Crohn Disease
• Interventions: Biological: Biological samplings; Other: Questionnaires

• Registration Number: NCT02504255
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.

The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.

Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.

Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.

This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.

This work also will specify the evolution of different markers at the moment of thrust

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Patient over 18 years.
• Patient with CD previously diagnosed according to standard criteria.
• Patient remission (HBS≤4) for at least 3 months and has not received corticosteroids (including budesonide) in the 3 months before.
• Patient without concomitant treatment of Crohn's disease or as stable dose (5-ASA, corticosteroids, immunosuppressants, anti-TNF) immunosuppressants (azathioprine, Purinethol, methotrexate) and / or anti-TNF and / or 5- amino salicylates (5-ASA) for at least 6 months.
• Patient who signed a consent.
• Patient affiliated to a social security scheme.

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Exclusion Criteria

• A patient with an active CD (HB score≥5).
• Patient who relapsed in the previous three months before inclusion.
• Patient who received corticosteroids (including budesonide) in the 6 months prior to inclusion.
• Patients on stable dose of non-anti-TNF in the 6 months prior to inclusion.
• Patient taking nonsteroidal anti-inflammatory drugs or antibiotics.
• Patient with complications of intestinal sub-occlusion type fistulas or abdominal abscesses.
• Patient with exclusive perianal disease or a predominate perianal manifestation.
• Pregnant women (examination).
• Patient who is the subject of extensive intestinal resection (> 1 m).
• Patient with ileostomy or colostomy.
• Patient on legal protection measure or who does not have the legal capacity to consent
• Lack of signed written consent of the patient.-

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Crohn's Disease	Questionnaires	patients will have biological samplings (blood, urine and faecal sampling) and will fill questionnaires to assess their stress and adaptation
Patients with Crohn's Disease	Biological samplings	patients will have biological samplings (blood, urine and faecal sampling) and will fill questionnaires to assess their stress and adaptation

Primary Outcome Measures

Name	Time	Method
Correlation between new immunological markers rate and Crohn's Disease relapse	within 15 months	This outcome will help us to show that regular monitoring of new immunological markers (serum markers of cytotoxicity of lymphocytes, pro- and anti-inflammatory cytokines and urinary and fecal neopterin) let us predict relapse of the disease

Secondary Outcome Measures

Name	Time	Method
Correlation between usual immunological markers rate and Crohn's Disease relapse	within 15 months	This outcome will help us to test the ability of inflammatory markers which are already routinely used for diagnostic purposes to predict relapse of CD. These "usual" markers are : fecal calprotectin and lactoferrin, serum ultrasensitive C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR)) is being evaluated (serum S100A12 protein, fecal, alpha-1-glycoprotein (orosomucoid) alpha-2 globulin)

Trial Locations

Locations (3)

CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie; 🇫🇷 Clermont-ferrand, France

Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie; 🇫🇷 Pierre Benite, France

CHU Hôpital Nord - Service d'Hépato-Gastroentérologie; 🇫🇷 Saint-etienne, France