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

NCT02504255 | Completed DMC

• 1 other identifier: 2010.630
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 3

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

Keywords

Crohn disease; inflammatory biomarkers; immunologic markers; calprotectin

Outcome Measures

Primary Outcomes (1)

• Correlation between new immunological markers rate and Crohn's Disease relapse

  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

  within 15 months

Secondary Outcomes (1)

• Correlation between usual immunological markers rate and Crohn's Disease relapse

  within 15 months

Study Arms (1)

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: Biological samplings; Other: Questionnaires

Interventions

Biological samplings BIOLOGICAL

Blood, urine and faecal sampling every 3 months

Patients with Crohn's Disease

Questionnaires OTHER

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

Patients with Crohn's Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn Disease

You may qualify if:

• 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.

You may not qualify if:

• A patient with an active CD (HB score≥5).
• 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.-

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie

Clermont-Ferrand, 63000, France

Location

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

Pierre-Bénite, 69495, France

Location

CHU Hôpital Nord - Service d'Hépato-Gastroentérologie

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 21, 2015
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

FR (3)