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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
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 18, 2016
Last Updated
March 13, 2023
Sponsor
University Hospital, Clermont-Ferrand
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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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