NCT02970513

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

March 14, 2023

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

November 18, 2016

Last Update Submit

March 13, 2023

Conditions

Colorectal Cancer

Keywords

Escherichia coliMicrobiotaColorectal cancerPsychiatric disordersPersonality traits

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Psychiatric prevalence comparison

    at day 1

  • personality traits comparison

    at day 1

Study Arms (1)

patients operated on for colorectal cancer

EXPERIMENTAL
Other: Psychiatric evaluation

Interventions

Psychiatric evaluationOTHER

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

patients operated on for colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with dementia will not be included, according to the MMSE score:
  • if no grade
  • if study certificate or CAP or college without patent
  • if patent or school without the tray
  • or more when bin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEscherichia coli InfectionsMental Disorders

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Isabelle JALENQUES

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 22, 2016

Study Start

March 27, 2017

Primary Completion

September 27, 2017

Study Completion

October 27, 2017

Last Updated

March 14, 2023

Record last verified: 2019-02

Locations

FR(1)