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Cognition and Emotion in the SII and IBD

Etude de la réactivité émotionnelle Des Patients MICI ou SII

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01095042
Acronym
EMOTION
Enrollment
120
Registered
2010-03-29
Start date
2008-10-31
Completion date
2013-05-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HRV, emotion, cognition, stress, cortisol, Autonomic nervous system

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.

Interventions

BEHAVIORALemotion

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.

Sponsors

French National Society of Gastroenterology
CollaboratorOTHER
Association François Aupetit
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY24 MONTHS

Secondary

MeasureTime frame
SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.24 MONTHS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026