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Completed

NCT Number: NCT02970513

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

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

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Key information

Conditions

Colorectal Cancer Bacterial Infections Bacterial Infections and Mycoses Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Enterobacteriaceae Infections Escherichia coli Infections Gastrointestinal Diseases Gastrointestinal Neoplasms Gram-Negative Bacterial Infections Infections Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychiatric evaluation

Other

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

Primary outcomes

  1. Hamilton anxiety and depression score comparison

    Time frame: at day 1

    Hamilton anxiety and depression score will be compared between patients with Escherichi coli colonic colonization and patients without Escherichi coli

Secondary outcomes

  1. Psychiatric prevalence comparison

    Time frame: at day 1

    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.

  2. personality traits comparison

    Time frame: at day 1

    personality traits investigated using Personality Inventory for DSM-5 (PID-5) will be compared in patients according colonic colonization by Escherichia coli

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: MicrobioPSY

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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