Clinical trial NCT01095042: Cognition and Emotion in the SII and IBD
Official title: Etude de la réactivité émotionnelle Des Patients MICI ou SII
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Inflammatory Bowel Disease (IBD)
Crohn's Disease(CD)
Ulcerative Colitis
Keywords: HRV
emotion
cognition
stress
cortisol
Autonomic nervous system
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: French National Society of Gastroenterology
name: Association François Aupetit
First posted: 2010-03-29
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.

Detailed description: The objective of the study which we wish to lead consists in looking for, at the patients SII and IBD in forgiveness, the existence of a correlation between the rate of cortisol(Hormone of the stress) and the level of HRV (Heart Rate Variability) to estimate the inhibitive fronto-amygdalien tonus.

So we make the hypothesis that the persons affected by digestive pathologies of type SII or IBD would present an emotional and physiological vulnerability more important than unhurt subjects of pathologies.

Eligibility criteria: Inclusion Criteria:

* Patients with SII :Membership to the Social Security,SII defined according to the criteria Rome III.
* Patients with IBD :Membership to the Social Security,patients with a ulcerative colitis(UC) or a Crohn's disease (CD)ileal and/or colic.

Exclusion Criteria:

* Existence of a severe affectation on the general plan (cardiac,respiratory,hematological,renal,hepatic,cancerous),
* Subject diabetic,
* Pregnant or breast-feeding woman,
* Subject included in another clinical and\\or therapeutic trial or having been included in a clinical and\\or therapeutic trial for less than a month,
* Subject presenting a psychiatric pathology evident,
* Person under guardianship.

Primary outcomes:
measure: RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
timeFrame: 24 MONTHS
Secondary outcomes:
measure: SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.
timeFrame: 24 MONTHS
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hôpital Michallon-CHU Grenoble
Study officials:
name: Bruno Bonaz, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pellissier S, Dantzer C, Canini F, Mathieu N, Bonaz B. Psychological adjustment and autonomic disturbances in inflammatory bowel diseases and irritable bowel syndrome. Psychoneuroendocrinology. 2010 Jun;35(5):653-62. doi: 10.1016/j.psyneuen.2009.10.004. Epub 2009 Nov 11.
citation: Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009.529. Epub 2009 Sep 15.
citation: Pellissier S, Dantzer C, Canini F, Mathieu N, Bonaz B. Toward a definition of a global psycho-physiological criterion of vulnerability to relapse in inflammatory bowel diseases. Am J Gastroenterol. 2010 Jun;105(6):1446-7. doi: 10.1038/ajg.2009.763. No abstract available.