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

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Hôpital Hôtel Dieu - Service d'Hépato-Gastroentérologie, Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

Biological samplings

Biological

Blood, urine and faecal sampling every 3 months

questionnaires

Other

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

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 21, 2015
Registry last updated: Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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