Inflammatory Bowel DiseasesNKT-CSP/MICINCT02884557
NKT Role in the Regulation of the Inflammatory Bowel Disease
A study testing collection of gut biopsies collection of blood samples in people with Inflammatory Bowel Diseases and Primary Sclerosing Cholangitis, run by University Hospital, Lille at 1 site in France.
Trial summary
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Primary Sclerosing Cholangitis
- What is being tested?
- collection of gut biopsies collection of blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to 28 Aug 2019
- 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 with PSC alone, IBD alone or PSC + IBD
- Obtention of oral and written consent
- Patients affiliated with the social security system
Who cannot join
- Minor patient
- Suspicion of malignant lesion of the colon
- Inability for information
- person unable to consent, and not benefiting from a legal protection regimen
- Person deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.
Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.
- Being tested
- collection of gut biopsies collection of blood samples
- Medical subject headings
- Inflammatory Bowel Diseases, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of gut biopsies collection of blood samplesOther
Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.
| Study group | Role | What they receive |
|---|---|---|
| PSC + IBD group | Other | collection of gut biopsies collection of blood samples in patients with PSC and IBD Receives: Other: collection of gut biopsies collection of blood samples |
| IBD alone group | Other | collection of gut biopsies collection of blood samples in patients with IBD alone Receives: Other: collection of gut biopsies collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
The number of NKT infiltrating colonic biopsies, using immunohistochemical staining
Measured: Through study completion, an average of 1 year
The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry
Measured: At the time of the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startMay 2013
- Primary completion27 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Desreumeaux, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884557
- Sponsor's protocol ID
- 2011_06
- Other IDs
- 2012-A00493-40
- Acronym
- NKT-CSP/MICI
- Status last verified
- Mar 2020
- First submitted
- 23 Aug 2016
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT02884557
- Acronym / sponsor ID
- NKT-CSP/MICI / 2011_06
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 31 Aug 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.
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.
Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSC + IBD group | Other | Other: collection of gut biopsies collection of blood samplescollection of gut biopsies collection of blood samples in patients with PSC and IBD |
| IBD alone group | Other | Other: collection of gut biopsies collection of blood samplescollection of gut biopsies collection of blood samples in patients with IBD alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with PSC alone, IBD alone or PSC + IBD
- Obtention of oral and written consent
- Patients affiliated with the social security system
Key exclusion criteria (5 listed)
- Minor patient
- Suspicion of malignant lesion of the colon
- Inability for information
- person unable to consent, and not benefiting from a legal protection regimen
- Person deprived of liberty
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 |
|---|---|---|
| collection of gut biopsies collection of blood samplesFour to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled. | Other | IBD alone group, PSC + IBD group |
Primary outcome
The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone
Time frame: Through study completion, an average of 1 year
2 secondary outcomes
The number of NKT infiltrating colonic biopsies, using immunohistochemical staining
Time frame: Through study completion, an average of 1 year
The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry
Time frame: At the time of the inclusion
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 27 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Pierre Desreumeaux, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of gut biopsies collection of blood samples in people with Inflammatory Bowel Diseases and Primary Sclerosing Cholangitis, run by University Hospital, Lille 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 3 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 27 Aug 2020. 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?
The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone (time frame: Through study completion, an average of 1 year). 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 27 Aug 2020.