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

Colorectal Cancer Clinical Trial

— MicrobioPSY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970513
• Other study ID #: CHU-0288
• Secondary ID: 2016-A01233-48
• Status: Completed
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Escherichia coli Infections

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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