IBDImmunoIBDNCT03366090
Immunological Profiles in Inflammatory Bowel Disease
An observational study of IBD and Immunology, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD, Immunology, Crohn Disease
- What is being tested?
- Biopsies during coloscopy
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2017to 1 Jul 2020
- 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: The study population will include newly diagnosed adults with IBD and the same patients under treatment during follow up.
Who may be able to join
- A patient who meets the following criteria will be included in this study:
- Patients with clinical symptoms of chronic diarrhoea, rectal blood loss, abdominal pain or weight loss who underwent ileocolonoscopy. Macroscopic findings during ileocolonoscopy must suggest IBD, such as erythema, mucosal friability, oedema an bleeding, erosions, superficial or deep ulcerations and luminal narrowing.
- Ultimately, the diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria.
- Patients must be able and willing to provide written informed consent.
- Patients above the age of 18, both men and women. AND/OR
- Known IBD patients under treatment during follow up.
Who cannot join
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Possible new IBD patients who use immunosuppressive medication 4 weeks prior to inclusion (e.g. corticosteroids and anti-TNF therapy) either for IBD, other autoimmune diseases or after organ transplantation.
- Patients diagnosed with an immune suppressive disease.
- Patients who underwent splenectomy in the past.
- Patients diagnosed with any other autoimmune diseases (e.g. Diabetes Mellitus type I, rheumatoid arthritis, celiac disease, psoriasis, systemic lupus erythematosus).
- Patients diagnosed with cancer including hematologic malignancies (e.g. (non-)Hodgkin lymphoma , leukemia), solid tumors and carcinoma in situ, within 5 years before screening with the following caveats:
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- Local basal or squamous cell carcinoma of the skin that has been excised and is considered cured is not exclusionary.
- Chronic myelogenous leukemia, hairy cell leukemia, melanoma, renal cell carcinoma, or Kaposi sarcoma are exclusionary irrespective of the duration of time before screening.
- Cervical smear indicating the presence of adenocarcinoma I situ (AIS), high-grade squamous intraepithelial lesions (HSIL), or cervical intraepithelial neoplasia (CIN) of grade>1, is exclusionary, irrespective of the duration of time before screening.
- Follow up IBD-patients who underwent a total colectomy in the past.
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.
Read the detailed description
Rationale: Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.
Objective: Determine if assessment of mucosal and serological immunological characteristics in combination with clinical indicators of disease behaviour and response to therapy can identify immune-based phenotypes with implications for prognosis and therapeutic interventions.
Study design: The study will be a longitudinal, prospective cohort study. Study population: The study population will include newly diagnosed adults fulling the diagnostic criteria for IBD. These patients will be further studied as a follow up cohort.
Intervention: Immunological analysis of extra mucosal biopsies and venous bloodsamples taken during regular ileocolonoscopy and labcontrols at initial diagnosis and during follow up.
Main study parameters/endpoints: The description of the different mucosal and serological immunological profiles at baseline and follow up in newly diagnosed IBD patients and the correlation between these different immunological profiles and clinical indicators of disease activity, disease course and response to the received therapy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Ileocolonoscopy with biopsies is a standard examination in patients presenting with chronic (+/- bloody) diarrhoea and in the follow up of patients with IBD. Collection of biopsies during the gastroenterological endoscopy, ie without interventions like polypectomy, is a safe procedure (bleeding, perforation <0,001). In the regular clinical practice, different endoscopists take a variable number of biopsies (4-10) from sites of interest. The intervention in this study comprises taking 4 additional biopsies on top of the regular histological biopsies for immunological examination.
Before ileocolonoscopy, patients normally receive an infusion needle for the administration of sedation (standard care). After ileocolonoscopy this needle will be used to take a venous blood sample. If this is not possible, we take a venous bloodsample during a regular labcontrol. In the follow up period, during regular endoscopies and blood checks the same additional samples will be taken.
Therefore, we believe the burden and risks for patients are minimalised.
- Conditions
- IBD, Immunology, Crohn Disease, Ulcerative Colitis, T Cell Subsets, Immunological Profiles
- Being tested
- Biopsies during coloscopy
- 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.
Biopsies during coloscopyProcedure or surgery
During standard ileocolonoscopy intestinal biopsy specimens of the macroscopically most inflamed ileal and colonic mucosa will be obtained at the moment of presentation and during follow up.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Biopsies for immunological analyses Receives: Procedure: Biopsies during coloscopy | |
| healthy controls | Biopsies for immunological analyses Receives: Procedure: Biopsies during coloscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
Measured: 10-2017 till 6-2020
Secondary outcomes (1)
The correlation between these different immunologic profiles and clinical indicators of disease activity, disease course and response to the received therapy.
The correlation between these different immunologic profiles and clinical indicators of disease activity, disease course and response to the received therapy.
Measured: 10-2017 till 6-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Oct 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roosenboom, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366090
- Sponsor's protocol ID
- NL62103.091.17
- Acronym
- ImmunoIBD
- Status last verified
- Dec 2017
- First submitted
- 16 Jun 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Profiles in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03366090
- Acronym / sponsor ID
- ImmunoIBD / NL62103.091.17
- Conditions
- IBD, Immunology, Crohn Disease, Ulcerative Colitis, T Cell Subsets, Immunological Profiles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 8 Dec 2017 (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.
Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.
Detailed description
Rationale: Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.
Objective: Determine if assessment of mucosal and serological immunological characteristics in combination with clinical indicators of disease behaviour and response to therapy can identify immune-based phenotypes with implications for prognosis and therapeutic interventions.
Study design: The study will be a longitudinal, prospective cohort study. Study population: The study population will include newly diagnosed adults fulling the diagnostic criteria for IBD. These patients will be further studied as a follow up cohort.
Intervention: Immunological analysis of extra mucosal biopsies and venous bloodsamples taken during regular ileocolonoscopy and labcontrols at initial diagnosis and during follow up.
Main study parameters/endpoints: The description of the different mucosal and serological immunological profiles at baseline and follow up in newly diagnosed IBD patients and the correlation between these different immunological profiles and clinical indicators of disease activity, disease course and response to the received therapy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Ileocolonoscopy with biopsies is a standard examination in patients presenting with chronic (+/- bloody) diarrhoea and in the follow up of patients with IBD. Collection of biopsies during the gastroenterological endoscopy, ie without interventions like polypectomy, is a safe procedure (bleeding, perforation <0,001). In the regular clinical practice, different endoscopists take a variable number of biopsies (4-10) from sites of interest. The intervention in this study comprises taking 4 additional biopsies on top of the regular histological biopsies for immunological examination.
Before ileocolonoscopy, patients normally receive an infusion needle for the administration of sedation (standard care). After ileocolonoscopy this needle will be used to take a venous blood sample. If this is not possible, we take a venous bloodsample during a regular labcontrol. In the follow up period, during regular endoscopies and blood checks the same additional samples will be taken.
Therefore, we believe the burden and risks for patients are minimalised.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Procedure: Biopsies during coloscopyBiopsies for immunological analyses |
| healthy controls | – | Procedure: Biopsies during coloscopyBiopsies for immunological analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include newly diagnosed adults with IBD and the same patients under treatment during follow up.
Key inclusion criteria (6 listed)
- A patient who meets the following criteria will be included in this study:
- Patients with clinical symptoms of chronic diarrhoea, rectal blood loss, abdominal pain or weight loss who underwent ileocolonoscopy. Macroscopic findings during ileocolonoscopy must suggest IBD, such as erythema, mucosal friability, oedema an bleeding, erosions, superficial or deep ulcerations and luminal narrowing.
- Ultimately, the diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria.
- Patients must be able and willing to provide written informed consent.
- Patients above the age of 18, both men and women. AND/OR
Key exclusion criteria (10 listed)
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Possible new IBD patients who use immunosuppressive medication 4 weeks prior to inclusion (e.g. corticosteroids and anti-TNF therapy) either for IBD, other autoimmune diseases or after organ transplantation.
- Patients diagnosed with an immune suppressive disease.
- Patients who underwent splenectomy in the past.
- Patients diagnosed with any other autoimmune diseases (e.g. Diabetes Mellitus type I, rheumatoid arthritis, celiac disease, psoriasis, systemic lupus erythematosus).
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 |
|---|---|---|
| Biopsies during coloscopyDuring standard ileocolonoscopy intestinal biopsy specimens of the macroscopically most inflamed ileal and colonic mucosa will be obtained at the moment of presentation and during follow up. | Procedure or surgery | IBD patients, healthy controls |
Primary outcome
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
Time frame: 10-2017 till 6-2020
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients
1 secondary outcome
The correlation between these different immunologic profiles and clinical indicators of disease activity, disease course and response to the received therapy.
Time frame: 10-2017 till 6-2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- 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.
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 IBD and Immunology, run by Rijnstate Hospital at 1 site in Netherlands.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Dec 2017. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact B Roosenboom, Msc (+31646623097, broosenboom@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients (time frame: 10-2017 till 6-2020). 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 8 Dec 2017.