NCT01095042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

4.6 years

First QC Date

February 22, 2010

Last Update Submit

January 27, 2014

Conditions

Irritable Bowel SyndromeInflammatory Bowel Disease (IBD)Crohn's Disease(CD)Ulcerative Colitis

Keywords

HRVemotioncognitionstresscortisolAutonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY

    24 MONTHS

Secondary Outcomes (1)

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

    24 MONTHS

Study Arms (2)

Control group

EXPERIMENTAL

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

Behavioral: emotion

Experimental group

EXPERIMENTAL

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.

Behavioral: emotion

Interventions

emotionBEHAVIORAL

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.

Also known as: STRESS
Control groupExperimental group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Michallon-CHU Grenoble

Grenoble, 38000, France

Location

Related Publications (3)

  • 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.

    PMID: 19910123BACKGROUND

  • 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.

    PMID: 19755973BACKGROUND

  • 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.

    PMID: 20523319BACKGROUND

MeSH Terms

Conditions

Irritable Bowel SyndromeInflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisColitis

Study Officials

  • Bruno Bonaz, MD-PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

March 29, 2010

Study Start

October 1, 2008

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

FR(1)