- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01095042
Cognition and Emotion in the SII and IBD (EMOTION)
Etude de la réactivité émotionnelle Des Patients MICI ou SII
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Grenoble, France, 38000
- Hôpital Michallon-CHU Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Control group
30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.
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Show that the susceptibility in the stress (recording of Heart Rate Variability;viewing films;...) is more important at the person affected by digestive pathologies (SII or IBD) in forgiveness than to unhurt subjects of pathologies.
Other Names:
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EXPERIMENTAL: Experimental group
Persons reached by digestive pathologies (SII or IBD). Group SII : 30 patients Group IBD: 60 patients (30 patients RCH and 30 patients CD) Intervention : Observation of emotional behavior in person affected by digestive pathologies subjected to stress. |
Show that the susceptibility in the stress (recording of Heart Rate Variability;viewing films;...) is more important at the person affected by digestive pathologies (SII or IBD) in forgiveness than to unhurt subjects of pathologies.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Time Frame: 24 MONTHS
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24 MONTHS
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.
Time Frame: 24 MONTHS
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24 MONTHS
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruno Bonaz, MD-PhD
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0817
- 2008-A00994-51 (REGISTRY: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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