Colorectal CancerMicrobioPSYNCT02970513
Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery
A study testing Psychiatric evaluation in people with Colorectal Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Psychiatric evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Psychiatric evaluation
- Keywords
- Escherichia coli, Microbiota, Colorectal cancer, Psychiatric disorders, Personality traits
- Medical subject headings
- Colorectal Neoplasms, Escherichia coli Infections, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric evaluationOther
The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.
| Study group | Role | What they receive |
|---|---|---|
| patients operated on for colorectal cancer | Experimental | Not described Receives: Other: Psychiatric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (2)
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.
Measured: 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
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start27 Mar 2017
- Primary completion27 Sep 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle JALENQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970513
- Sponsor's protocol ID
- CHU-0288
- Other IDs
- 2016-A01233-48
- Acronym
- MicrobioPSY
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2016
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rondepierre F, Meynier M, Gagniere J, Deneuvy V, Deneuvy A, Roche G, Baudu E, Pereira B, Bonnet R, Barnich N, Carvalho FA, Pezet D, Bonnet M, Jalenques I. Preclinical and clinical evidence of the association of colibactin-producing Escherichia coli with anxiety and depression in colon cancer. World J Gastroenterol. 2024 Jun 7;30(21):2817-2826. doi: 10.3748/wjg.v30.i21.2817.
PubMed 38899326
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02970513
- Acronym / sponsor ID
- MicrobioPSY / CHU-0288
- Conditions
- Colorectal Cancer
- Keywords
- Escherichia coli, Microbiota, Colorectal cancer, Psychiatric disorders, Personality traits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients operated on for colorectal cancer | Experimental | Other: Psychiatric evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric evaluationThe purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders. | Other | patients operated on for colorectal cancer |
Primary outcome
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
2 secondary outcomes
Psychiatric prevalence comparison
Time frame: at day 1
personality traits comparison
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 38899326Rondepierre F, Meynier M, Gagniere J, Deneuvy V, Deneuvy A, Roche G, Baudu E, Pereira B, Bonnet R, Barnich N, Carvalho FA, Pezet D, Bonnet M, Jalenques I. Preclinical and clinical evidence of the association of colibactin-producing Escherichia coli with anxiety and depression in colon cancer. World J Gastroenterol. 2024 Jun 7;30(21):2817-2826. doi: 10.3748/wjg.v30.i21.2817.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle JALENQUES principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric evaluation in people with Colorectal Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton anxiety and depression score comparison (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.