Cognition and Emotion in the SII and IBD (EMOTION)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

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

Treatments: Behavioral: emotion

Study type: Interventional

Funder types: Other

Identifiers

NCT01095042

0817

2008-A00994-51 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control group

Experimental group

Description:

30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.

Treatment:

Behavioral: emotion

Experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: emotion