Crohn's DiseaseROMANNCT03404557
Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to AIEC
An observational study of Crohn's Disease and Ulcerative Colitis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Proteomic analysis
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2018to 18 Jan 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Crohn's disease
Who may be able to join
- - Crohn's Disease or ulcerative colitis or healthy volunteers
- Age > 18 years
- Patients benefiting from the health insurance plan
- Patients who can read and attest to understanding the information note and informed consent
Who cannot join
- Pregnant or breastfeeding woman
- Under guardianship or curatorship
- Refusing the genetic part of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to Adherent-Invasive Escherichia Coli
The M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages.
That's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.
Read the detailed description
The macrophages characterization will be realized at a basal state and in response or not to AIEC.
Investigator aimed to 1) better understand the differences between macrophages of CD patients, UC patients and healthy volunteers but also the impact of AIEC infection on these macrophages to provide key informations to detect and characterize the defect of these macrophages; 2) highlight one or several protein in CD macrophages that could represent, in a long term, a potential therapeutic target of CD.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Proteomic analysis
- Keywords
- Crohn's Disease, Ulcerative colitis, Macrophages, Adherent-Invasive Escherichia coli, Proteomic analysis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic analysisOther
Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease patients group | 44 patients Receives: Other: Proteomic analysis | |
| Ulcerative Colitis patients group | 22 patients Receives: Other: Proteomic analysis | |
| Healthy volunteers group | 22 patients Receives: Other: Proteomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state
Compare concentrations of different protein types in the supernatant of macrophages from patients with CD through proteomic approaches, compared with patients with UC or controls.
Measured: at day 1
Secondary outcomes (8)
Comparison of concentrations of different protein types in the supernatant of macrophages
Measured: at day 1
presence of subgroups of patients with CD based on the proteomic profile of their macrophages.
Measured: at day 1
association between these subgroups of patients with CD and biological parameters.
Measured: at day 1
associations between the proteomic profiles of macrophages of patients with CD, UC or control subjects and fecal AIEC status
Measured: at day 1
associations between the levels of entry, survival and multiplication of AIEC bacteria
Measured: at day 1
impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CD
Measured: at day 1
associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC status
Measured: at day 1
associations between the Proteomic profile (s) of tissue macrophages and their AIEC status
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 posted19 Jan 2018
- Study start18 Jan 2018
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire M2Ish
- Responsible party
- Sponsor
- Investigators
- Anthony BUISSON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404557
- Sponsor's protocol ID
- CHU-370
- Other IDs
- 2017-A00667-46
- Acronym
- ROMAN
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of Crohn's Disease Macrophages in Response or Not to Adherent-Invasive Escherichia Coli
- ClinicalTrials.gov ID
- NCT03404557
- Acronym / sponsor ID
- ROMAN / CHU-370
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's Disease, Ulcerative colitis, Macrophages, Adherent-Invasive Escherichia coli, Proteomic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire M2Ish
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 19 Jan 2018 (actual)
- 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 M2iSH laboratory showed with two previous clinical trials that Crohn's Disease (CD) macrophages present i) a defect to control Adherent-Invasive Escherichia coli (AIEC) infection related to polymorphisms associated with CD; ii) a CD - specific cytokine secretion profile after an AIEC infection and intestinal inflammation dependent; iii) a modification of the response of CD macrophages at a basal state and after the AIEC infection. These results consolidate the hypothesis of a defect specific to CD macrophages.
That's why, the primary purpose of this study is to realize a proteomic analysis of macrophages of CD patients infected or not with AIEC and to compare them to Ulcerative Colitis (UC) patients and healthy volunteers.
Detailed description
The macrophages characterization will be realized at a basal state and in response or not to AIEC.
Investigator aimed to 1) better understand the differences between macrophages of CD patients, UC patients and healthy volunteers but also the impact of AIEC infection on these macrophages to provide key informations to detect and characterize the defect of these macrophages; 2) highlight one or several protein in CD macrophages that could represent, in a long term, a potential therapeutic target of CD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease patients group | – | Other: Proteomic analysis44 patients |
| Ulcerative Colitis patients group | – | Other: Proteomic analysis22 patients |
| Healthy volunteers group | – | Other: Proteomic analysis22 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn's disease
Key inclusion criteria (4 listed)
- - Crohn's Disease or ulcerative colitis or healthy volunteers
- Age > 18 years
- Patients benefiting from the health insurance plan
- Patients who can read and attest to understanding the information note and informed consent
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Under guardianship or curatorship
- Refusing the genetic part of the study
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 |
|---|---|---|
| Proteomic analysisProteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli | Other | Crohn's Disease patients group, Healthy volunteers group, Ulcerative Colitis patients group |
Primary outcome
Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state
Time frame: at day 1
Compare concentrations of different protein types in the supernatant of macrophages from patients with CD through proteomic approaches, compared with patients with UC or controls.
8 secondary outcomes
Comparison of concentrations of different protein types in the supernatant of macrophages
Time frame: at day 1
presence of subgroups of patients with CD based on the proteomic profile of their macrophages.
Time frame: at day 1
association between these subgroups of patients with CD and biological parameters.
Time frame: at day 1
associations between the proteomic profiles of macrophages of patients with CD, UC or control subjects and fecal AIEC status
Time frame: at day 1
associations between the levels of entry, survival and multiplication of AIEC bacteria
Time frame: at day 1
impact of anti-TNF treatment on the proteomic profile (s) observed for macrophages of patients with CD
Time frame: at day 1
associations between the Proteomic profile (s) of the macrophages derived from monocytes and their AIEC status
Time frame: at day 1
associations between the Proteomic profile (s) of tissue macrophages and their AIEC status
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 4 Feb 2019.
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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.
Anthony BUISSON 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?
An observational study of Crohn's Disease and Ulcerative Colitis, 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 3 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 4 Feb 2019. 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?
Compare the proteomic profile of macrophages of patients with CD to patients with UC and healthy subjects in the basal state (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?
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 4 Feb 2019.