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

NCT ID: NCT02504255

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-04-30

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

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Crohn's Disease

patients will have biological samplings (blood, urine and faecal sampling) and will fill questionnaires to assess their stress and adaptation

Biological samplings

Intervention Type: BIOLOGICAL

Blood, urine and faecal sampling every 3 months

Questionnaires

Intervention Type: OTHER

patients fill several questionnaires every month to assess stress and adaptation parameters

Interventions

Biological samplings

Blood, urine and faecal sampling every 3 months

Intervention Type: BIOLOGICAL

Questionnaires

patients fill several questionnaires every month to assess stress and adaptation parameters

Intervention Type: OTHER

Eligibility Criteria

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.

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.-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie

Clermont-Ferrand, , France

Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Hépato-Gastroentérologie

Pierre-Bénite, , France

CHU Hôpital Nord - Service d'Hépato-Gastroentérologie

Saint-Etienne, , France

Countries

France

Other Identifiers

2010.630

Identifier Type: -

Identifier Source: org_study_id