Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery (MicrobioPSY)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychiatric evaluation
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Escherichia coli, Microbiota, Colorectal cancer, Psychiatric disorders, Personality traits
Eligibility Criteria
Inclusion Criteria:
- patients operated on for colorectal cancer in the digestive surgery department of Clermont-Ferrand hospital
- patients older than 18 years,
- patients whose Escherichia coli colonization was analyzed after surgery
- patients which are always followed by the digestive surgery department.
Exclusion Criteria:
- Patients with dementia will not be included, according to the MMSE score:
- 22 if no grade
- 23 if study certificate or CAP or college without patent
- 25 if patent or school without the tray
- 26 or more when bin
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients operated on for colorectal cancer
Arm Description
Outcomes
Primary Outcome Measures
Hamilton anxiety and depression score comparison
Hamilton anxiety and depression score will be compared between patients with Escherichi coli colonic colonization and patients without Escherichi coli
Secondary Outcome Measures
Psychiatric prevalence comparison
prevalence of each past and actual psychiatric disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI: major depression, dysthymia, suicidal risk, hypomania, mania, panic disorder, agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder, posttraumatic stress disorder, dependence and abuse of alcohol, tobacco- dependence, psychotic disorders and generalized anxiety disorder) will be compared in patients according to colonic colonization by Escherichia coli.
personality traits comparison
personality traits investigated using Personality Inventory for DSM-5 (PID-5) will be compared in patients according colonic colonization by Escherichia coli
Full Information
NCT ID
NCT02970513
First Posted
November 18, 2016
Last Updated
March 13, 2023
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02970513
Brief Title
Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery
Acronym
MicrobioPSY
Official Title
Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
September 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.
Detailed Description
Colonic colonization by pathogenic Escherichia coli was determined when patients were operated on for colorectal cancer.
Several years later, the investigator investigate past and actual psychiatric disorder using the Mini International Neuropsychiatric Interview (MINI). Actual depression and anxiety scores are evaluated with Hamilton scales and personality traits are investigated using Personality Inventory for DSM-5 (PID-5).
Anxiety and depression scores, psychiatric diagnoses (MINI) and personality traits were compared in patients according to Escherichia coli presence/absence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Escherichia coli, Microbiota, Colorectal cancer, Psychiatric disorders, Personality traits
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients operated on for colorectal cancer
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Psychiatric evaluation
Intervention Description
The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.
Primary Outcome Measure Information:
Title
Hamilton anxiety and depression score comparison
Description
Hamilton anxiety and depression score will be compared between patients with Escherichi coli colonic colonization and patients without Escherichi coli
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Psychiatric prevalence comparison
Description
prevalence of each past and actual psychiatric disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI: major depression, dysthymia, suicidal risk, hypomania, mania, panic disorder, agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder, posttraumatic stress disorder, dependence and abuse of alcohol, tobacco- dependence, psychotic disorders and generalized anxiety disorder) will be compared in patients according to colonic colonization by Escherichia coli.
Time Frame
at day 1
Title
personality traits comparison
Description
personality traits investigated using Personality Inventory for DSM-5 (PID-5) will be compared in patients according colonic colonization by Escherichia coli
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients operated on for colorectal cancer in the digestive surgery department of Clermont-Ferrand hospital
patients older than 18 years,
patients whose Escherichia coli colonization was analyzed after surgery
patients which are always followed by the digestive surgery department.
Exclusion Criteria:
Patients with dementia will not be included, according to the MMSE score:
22 if no grade
23 if study certificate or CAP or college without patent
25 if patent or school without the tray
26 or more when bin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle JALENQUES
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery
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