Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery (MicrobioPSY)

The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Psychiatric evaluation

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients operated on for colorectal cancer	Other: Psychiatric evaluation; The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at day 1
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	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Isabelle JALENQUES, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): September 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Colorectal cancer; Microbiota; Psychiatric disorders; Escherichia coli; Personality traits
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Intestinal Neoplasms; Rectal Diseases; Enterobacteriaceae Infections; Colorectal Neoplasms; Escherichia coli Infections
• Other Study ID Numbers: CHU-0288; 2016-A01233-48 (Other Identifier: 2016-A01233-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No