Cognition and Emotion in the SII and IBD

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Disease (IBD); Crohn's Disease(CD); Ulcerative Colitis
• Interventions: Behavioral: emotion

• Registration Number: NCT01095042
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	emotion	30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.
Experimental group	emotion	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.

Primary Outcome Measures

Name	Time	Method
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY	24 MONTHS

Secondary Outcome Measures

Name	Time	Method
SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.	24 MONTHS

Trial Locations

Locations (1)

Hôpital Michallon-CHU Grenoble; 🇫🇷 Grenoble, France