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Cognition and Emotion in the SII and IBD (EMOTION)

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ClinicalTrials.gov Identifier: NCT01095042
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : January 28, 2014
Sponsor:
Collaborators:
French National Society of Gastroenterology
Association François Aupetit
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Inflammatory Bowel Disease (IBD) Crohn's Disease(CD) Ulcerative Colitis Behavioral: emotion Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Etude de la réactivité émotionnelle Des Patients MICI ou SII
Study Start Date : October 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control group
30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.
Behavioral: emotion
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 Name: STRESS

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.

Behavioral: emotion
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 Name: STRESS




Primary Outcome Measures :
  1. RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY [ Time Frame: 24 MONTHS ]

Secondary Outcome Measures :
  1. SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES. [ Time Frame: 24 MONTHS ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095042


Locations
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France
Hôpital Michallon-CHU Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
French National Society of Gastroenterology
Association François Aupetit
Investigators
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Principal Investigator: Bruno Bonaz, MD-PhD

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01095042     History of Changes
Other Study ID Numbers: 0817
2008-A00994-51 ( Registry Identifier: ID RCB )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by University Hospital, Grenoble:
HRV
emotion
cognition
stress
cortisol
Autonomic nervous system

Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Colonic Diseases, Functional