Etude de la réactivité émotionnelle Des Patients MICI ou SII
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Time Frame: 24 MONTHS
Secondary Outcomes
- SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.(24 MONTHS)