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Completed

NCT Number: NCT01095042

Cognition and Emotion in the SII and IBD

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.

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Key information

Conditions

Irritable Bowel Syndrome Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Crohn Disease Crohn's Disease(CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Michallon-CHU Grenoble

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

emotion

Behavioral

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 names: STRESS

Primary outcomes

  1. RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY

    Time frame: 24 MONTHS

Secondary outcomes

  1. SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.

    Time frame: 24 MONTHS

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Association François Aupetit
  • French National Society of Gastroenterology

Registry information

Official study title

Etude de la réactivité émotionnelle Des Patients MICI ou SII

Acronym: EMOTION

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2010
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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