search
Back to results

Cognition and Emotion in the SII and IBD (EMOTION)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
emotion
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome focused on measuring HRV, emotion, cognition, stress, cortisol, Autonomic nervous system

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Hôpital Michallon-CHU Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

Experimental group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2010
Last Updated
January 27, 2014
Sponsor
University Hospital, Grenoble
Collaborators
French National Society of Gastroenterology, Association François Aupetit
search

1. Study Identification

Unique Protocol Identification Number
NCT01095042
Brief Title
Cognition and Emotion in the SII and IBD
Acronym
EMOTION
Official Title
Etude de la réactivité émotionnelle Des Patients MICI ou SII
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
French National Society of Gastroenterology, Association François Aupetit

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Inflammatory Bowel Disease (IBD), Crohn's Disease(CD), Ulcerative Colitis
Keywords
HRV, emotion, cognition, stress, cortisol, Autonomic nervous system

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress.
Arm Title
Experimental group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
emotion
Other Intervention Name(s)
STRESS
Intervention Description
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.
Primary Outcome Measure Information:
Title
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Time Frame
24 MONTHS
Secondary Outcome Measure Information:
Title
SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.
Time Frame
24 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Bonaz, MD-PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Michallon-CHU Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19910123
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.
Results Reference
background
PubMed Identifier
19755973
Citation
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.
Results Reference
background
PubMed Identifier
20523319
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. No abstract available.
Results Reference
background

Learn more about this trial

Cognition and Emotion in the SII and IBD

We'll reach out to this number within 24 hrs