Cognition and Emotion in the SII and IBD

Ulcerative Colitis Clinical Trial

— EMOTION  

Official title:

Etude de la réactivité émotionnelle Des Patients MICI ou SII

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095042
• Other study ID #: 0817
• Secondary ID: 2008-A00994-51
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: January 27, 2014
• Start date: October 2008
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease(CD)
• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Michallon-CHU Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Association François Aupetit, French society of Gastroenterology

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY		24 MONTHS	No
Secondary	SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.		24 MONTHS	No