Irritable Bowel SyndromeEMOTIONNCT01095042
Cognition and Emotion in the SII and IBD
A study testing emotion in people with Irritable Bowel Syndrome and Inflammatory Bowel Disease (IBD), run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Inflammatory Bowel Disease (IBD), Crohn's Disease(CD)
- What is being tested?
- emotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Etude de la réactivité émotionnelle Des Patients MICI ou SII
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Inflammatory Bowel Disease (IBD), Crohn's Disease(CD), Ulcerative Colitis
- Being tested
- emotion
- Keywords
- HRV, emotion, cognition, stress, cortisol, Autonomic nervous system
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotionBehavioural
Also called STRESS
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | 30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress. Receives: 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. Receives: Behavioral: emotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Measured: 24 MONTHS
Secondary outcomes (1)
SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startOct 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- French National Society of Gastroenterology, Association François Aupetit
- Responsible party
- Sponsor
- Investigators
- Bruno Bonaz, MD-PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095042
- Sponsor's protocol ID
- 0817
- Other IDs
- 2008-A00994-51
- Acronym
- EMOTION
- Status last verified
- Jan 2014
- First submitted
- 22 Feb 2010
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19910123Graff 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.
PubMed 19755973Pellissier 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.
PubMed 20523319
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la réactivité émotionnelle Des Patients MICI ou SII
- ClinicalTrials.gov ID
- NCT01095042
- Acronym / sponsor ID
- EMOTION / 0817
- Conditions
- Irritable Bowel Syndrome, Inflammatory Bowel Disease (IBD), Crohn's Disease(CD), Ulcerative Colitis
- Keywords
- HRV, emotion, cognition, stress, cortisol, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- French National Society of Gastroenterology, Association François Aupetit
- Study start
- Oct 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Behavioral: emotion30 Asymptomatic Healthy Volunteers Intervention : Observation of emotional behavior in asymptomatic healthy volunteers subjected to stress. |
| Experimental group | Experimental | Behavioral: emotionPersons 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emotionAlso: STRESSShow 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. | Behavioural | Control group, Experimental group |
Primary outcome
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY
Time frame: 24 MONTHS
1 secondary outcome
SCORES OF DEPRESSIVE SYMPTOMATOLOGIE AND ANXIETY, RATE PLASMATIQUES OF CATECHOLAMINES, LEPTINE, ADIPONECTINE AND PRO-INFLAMMATORY CYTOKINES.
Time frame: 24 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Background: PubMed 19910123Pellissier 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.
- Background: PubMed 19755973Graff 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.
- Background: PubMed 20523319Pellissier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Bonaz, MD-PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotion in people with Irritable Bowel Syndrome and Inflammatory Bowel Disease (IBD), run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RATE PLASMATIQUE OF CORTISOL COUPLED WITH THE CARDIAC VARIABILITY (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01095042, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.