CrohnSUIVITHEQUE2NCT07172945
Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants.
A study testing Blood, fecal, saliva and intestinal content samples and biopsies in people with Crohn and Ulcerative Colitis (UC), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn, Ulcerative Colitis (UC), IBD (Inflammatory Bowel Disease)
- What is being tested?
- Blood, fecal, saliva and intestinal content samples and biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Nov 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- For all patients and control subjects
- Person able to give free and informed consent.
- Age ≥ 18 years.
- Beneficiary of a social protection scheme or entitled person (excluding AME).
- Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital
- Patients with IBD :
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- Patients with Crohn's disease or haemorrhagic rectocolitis with a diagnosis established or confirmed in the Gastroenterology and Nutrition Department at Saint-Antoine Hospital.
- Microbiota control' subjects:
- Healthy subjects seen in consultation as a preventive measure or as part of stool donations for FMT.
- Endoscopy control' subjects:
- Subjects with a medical indication for digestive endoscopy with biopsies:
- For upper endoscopy: moderate upper digestive symptoms such as epigastralgia or pyrosis
- For colonoscopy: moderate digestive symptoms suggestive of irritable bowel syndrome or screening for colorectal cancer.
Who cannot join
- For all patients and control subjects
- Subjects under guardianship, curatorship or safeguard of justice.
- Subjects who do not speak French.
- IBD patients:
- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
- Endoscopy control' and "microbiota control" subjects:
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- Subject suffering from a chronic disease
- Antibiotics taken in the 6 weeks prior to endoscopy
- Antibiotics or colonic preparation taken within 6 weeks prior to stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants
Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options.
The exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression.
Due to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.
Read the detailed description
Inflammatory Bowel Diseases (IBD) are chronic, disabling conditions that affect young adults with a predilection for flare-ups interspersed with periods of remission. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD.
IBD is a chronic disease, the course of which is often marked by complications. Until recently, the medical treatment of IBD was based on the use of immunosuppressants, particularly thiopurines. The management of IBD has been modified in recent years by the appearance of new so-called 'biological' treatments. Anti-TNFa antibodies (such as infliximab or adalimumab) represent, highly effective weapon in the arsenal available for treating IBD. Biological treatments appear to have a synergistic effect with thiopurines and their administration is therefore often concomitant. These immunosuppressive and biological treatments are not harmless, especially as they are taken for prolonged periods by young patients. In particular, the use of thiopurines is associated with a marked increase in the risk of non-melanoma skin cancers and lymphomas. The long-term risks of biological treatments are still poorly understood. For the treatment of IBD, there are now much more biologics available, including Ustekinumab, vedolizumab and also small molecules, such as JAK inhibitors.
Despite recent advances, the cause of IBD remains unknown. The currently dominant hypothesis is that of an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals.
In humans, an imbalance in the composition of the intestinal microbiota (dysbiosis) has been demonstrated in patients with CD and UC, with a reduction in 'beneficial' bacteria and an increase in potentially 'harmful' bacteria. Finally, certain bacteria in the intestinal microbiota could be used as a marker of disease activity or as a predictive factor for progression, as we have shown with the Faecalibacterium prausnitzii bacterium and postoperative recurrence of Crohn's disease.
Given the phenotypic heterogeneity of UC and CD in terms of progression and complications, it is essential to identify predictive factors that will enable patients at risk to be identified as early as possible so that treatment can be adapted at an early stage.
Given the clinical and pathophysiological heterogeneity of IBD, it would seem difficult to use clinical factors alone to predict patient outcome. On the other hand, it would also be very important to be able to predict the response or side-effects of a treatment before starting it, which again would enable appropriate decisions to be made without wasting time. It therefore seems necessary to look for biological determinants of the course and complications of IBD.
The aims of the study are (i) to identify biological determinants of the course, complications and response to treatment of chronic inflammatory bowel disease and (ii) to gain a better understanding of the underlying pathophysiological mechanisms.
The primary outcome is to describe the Biological parameters of the host and microbiota as a prognosis factor, and the response to treatment in IBD.
The secondary outcomes are lister below:
- Identification of genetic polymorphisms
- Identification of serum markers
- Identification of iImmune characteristics of the intestinal microbiota
- Identification of markers of the intestinal microbiota
- Mucosal characteristics of the intestinal microbiota
- Mucosal markers of the intestinal microbiota
- Mechanistic analysis: Exploratory study into the pathophysiology of host-microbiota interactions; interactions between epithelial cells, immune cells and micro-organisms and omics analysis including microbiome sequencing, transcriptomics, metabolomics, and functional assay will be perform to analyze the interactions between epithelial or immune cells with the gut microbiome
- Being tested
- Blood, fecal, saliva, intestinal content samples and biopsies
- Keywords
- Microbiome, Biobank, Crohn, Ulcerative colitis, IBD
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, fecal, salivaOther
Blood, fecal and saliva samples
intestinal content samples and biopsiesOther
intestinal content samples and biopsies obtained per upper or lower gastrointestinal tract endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients with Inflammatory Bowel Diseases | Other | Not described Receives: Other: Blood, fecal, saliva; Other: intestinal content samples and biopsies |
| Microbiota control' subjects | Other | Not described Receives: Other: Blood, fecal, saliva |
| Endoscopy control' subjects | Other | Not described Receives: Other: Blood, fecal, saliva; Other: intestinal content samples and biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD
identify relations between fecal and ileal microbiome and disease evolution
Measured: up to 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2040 (estimated)
- Study completionNov 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CrohnStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University
- Responsible party
- Sponsor
- Investigators
- Harry SOKOL, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172945
- Sponsor's protocol ID
- APHP240151
- Other IDs
- IDRCB: 2024-A00348-39
- Acronym
- SUIVITHEQUE2
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: plans to share these data outside the primary research group for secondary research purposes like re-analysis, secondary analysis, or meta-analysis. Data may be shared via an online platform, an email request, nonelectronic transfer, or other method
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Follow-up of the Determinants of the Progression and Complications of Inflammatory Bowel Diseases Treated or Not With Immunosuppressants
- ClinicalTrials.gov ID
- NCT07172945
- Acronym / sponsor ID
- SUIVITHEQUE2 / APHP240151
- Keywords
- Microbiome, Biobank, Crohn, Ulcerative colitis, IBD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sorbonne University
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2040 (estimated)
- Study completion
- Nov 2040 (estimated)
- First posted
- 15 Sep 2025 (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), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options.
The exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression.
Due to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.
Detailed description
Inflammatory Bowel Diseases (IBD) are chronic, disabling conditions that affect young adults with a predilection for flare-ups interspersed with periods of remission. Crohn's disease (CD) and ulcerative colitis (UC) are the two main types of IBD.
IBD is a chronic disease, the course of which is often marked by complications. Until recently, the medical treatment of IBD was based on the use of immunosuppressants, particularly thiopurines. The management of IBD has been modified in recent years by the appearance of new so-called 'biological' treatments. Anti-TNFa antibodies (such as infliximab or adalimumab) represent, highly effective weapon in the arsenal available for treating IBD. Biological treatments appear to have a synergistic effect with thiopurines and their administration is therefore often concomitant. These immunosuppressive and biological treatments are not harmless, especially as they are taken for prolonged periods by young patients. In particular, the use of thiopurines is associated with a marked increase in the risk of non-melanoma skin cancers and lymphomas. The long-term risks of biological treatments are still poorly understood. For the treatment of IBD, there are now much more biologics available, including Ustekinumab, vedolizumab and also small molecules, such as JAK inhibitors.
Despite recent advances, the cause of IBD remains unknown. The currently dominant hypothesis is that of an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals.
In humans, an imbalance in the composition of the intestinal microbiota (dysbiosis) has been demonstrated in patients with CD and UC, with a reduction in 'beneficial' bacteria and an increase in potentially 'harmful' bacteria. Finally, certain bacteria in the intestinal microbiota could be used as a marker of disease activity or as a predictive factor for progression, as we have shown with the Faecalibacterium prausnitzii bacterium and postoperative recurrence of Crohn's disease.
Given the phenotypic heterogeneity of UC and CD in terms of progression and complications, it is essential to identify predictive factors that will enable patients at risk to be identified as early as possible so that treatment can be adapted at an early stage.
Given the clinical and pathophysiological heterogeneity of IBD, it would seem difficult to use clinical factors alone to predict patient outcome. On the other hand, it would also be very important to be able to predict the response or side-effects of a treatment before starting it, which again would enable appropriate decisions to be made without wasting time. It therefore seems necessary to look for biological determinants of the course and complications of IBD.
The aims of the study are (i) to identify biological determinants of the course, complications and response to treatment of chronic inflammatory bowel disease and (ii) to gain a better understanding of the underlying pathophysiological mechanisms.
The primary outcome is to describe the Biological parameters of the host and microbiota as a prognosis factor, and the response to treatment in IBD.
The secondary outcomes are lister below:
- Identification of genetic polymorphisms
- Identification of serum markers
- Identification of iImmune characteristics of the intestinal microbiota
- Identification of markers of the intestinal microbiota
- Mucosal characteristics of the intestinal microbiota
- Mucosal markers of the intestinal microbiota
- Mechanistic analysis: Exploratory study into the pathophysiology of host-microbiota interactions; interactions between epithelial cells, immune cells and micro-organisms and omics analysis including microbiome sequencing, transcriptomics, metabolomics, and functional assay will be perform to analyze the interactions between epithelial or immune cells with the gut microbiome
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Inflammatory Bowel Diseases | Other | Other: Blood, fecal, saliva, Other: intestinal content samples and biopsies |
| Microbiota control' subjects | Other | Other: Blood, fecal, saliva |
| Endoscopy control' subjects | Other | Other: Blood, fecal, saliva, Other: intestinal content samples and biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For all patients and control subjects
- Person able to give free and informed consent.
- Age ≥ 18 years.
- Beneficiary of a social protection scheme or entitled person (excluding AME).
- Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital
Key exclusion criteria (9 listed)
- For all patients and control subjects
- Subjects under guardianship, curatorship or safeguard of justice.
- Subjects who do not speak French.
- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
- Subject suffering from a chronic disease
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 |
|---|---|---|
| Blood, fecal, salivaBlood, fecal and saliva samples | Other | Endoscopy control' subjects, Microbiota control' subjects, Patients with Inflammatory Bowel Diseases |
| intestinal content samples and biopsiesintestinal content samples and biopsies obtained per upper or lower gastrointestinal tract endoscopy | Other | Endoscopy control' subjects, Patients with Inflammatory Bowel Diseases |
Primary outcome
Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD
Time frame: up to 12 months after the inclusion
identify relations between fecal and ileal microbiome and disease evolution
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. plans to share these data outside the primary research group for secondary research purposes like re-analysis, secondary analysis, or meta-analysis. Data may be shared via an online platform, an email request, nonelectronic transfer, or other method
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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.
Harry SOKOL, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Blood, fecal, saliva and intestinal content samples and biopsies in people with Crohn and Ulcerative Colitis (UC), run by Assistance Publique - Hôpitaux de Paris.
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 13 inclusion and 9 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harry SOKOL, MD, PhD01 (+ 33 1 49 28 31 62, harry.sokol@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between biological parameters (fecal and ileal microbiome) and outcomes of IBD (time frame: up to 12 months after the inclusion). 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 15 Sep 2025.