SpondyloarthritisMISTNCT03359642
Characterization of the Intestinal Microbiota in Patients With Inflammatory Bowel Disease and/or Spondyloarthritis and Study of the Impact of an Anti-TNF Alpha Therapy
A study testing blood sample, stool samples and food questionnaire in people with Spondyloarthritis and Crohn Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Spondyloarthritis and inflammatory bowel diseases are common diseases, frequently met together in overlap syndromes. Their physiopathology remains puzzling. A strong role of gut microbiota has been recently put forward to explain the development of inflammatory bowel diseases, and is suspected to play an important… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Crohn Disease, Ulcerative Colitis
- What is being tested?
- blood sample, stool samples and food questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2018to 16 Sep 2021
- 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 aged over 18 years
- Patients with the following conditions :
- Ulcerative colitis (UC) fulfilling the ECCO criteria
- Crohn's disease (CD) fulfilling the ECCO criteria
- Axial or peripheral spondyloarthritis (SpA) fulfilling the Assessment of SpondyloArthritis (ASAS) criteria
- Patients naïve to anti-TNF alpha, justifying the initiation of an anti-TNF alpha treatment according to current guidelines (ECCO Inflammatory bowel disease (IBD) recommendations, the recommendations of the French Society of Rheumatology for SpA)
- Patients agreeing to sign the informed consent
Who cannot join
- Patient with an inflammatory disease other than UC, CD or SpA
- History of bowel resection or digestive stoma
- Taking antibiotics in the three months preceding the stool collection
- Patients with contraindication to treatment
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Spondyloarthritis and inflammatory bowel diseases are common diseases, frequently met together in overlap syndromes. Their physiopathology remains puzzling. A strong role of gut microbiota has been recently put forward to explain the development of inflammatory bowel diseases, and is suspected to play an important role in rheumatoid diseases. Anti-Tumor Necrosis Factor (anti-TNF) alpha are effective and safe drugs in the treatment of both digestive and rheumatoid inflammatory diseases. The way they work is unclear, and the clinical response to this treatment is variable. A better understanding of the pathophysiology of inflammatory bowel diseases and of the action of anti-TNF alpha is essential to an optimized care.
Our hypothesis is that the efficacy of anti-TNF alpha in spondyloarthritis and in inflammatory bowel diseases is at least partly due to its restoring action of homeostasis at the interface between gastrointestinal mucosa and intestinal microbiota, either by primary action on the digestive epithelium, allowing it to regain its control and tolerance functions toward mucosal microbiota, either by direct action on the intestinal microbiota, via an inter-reigns regulation.
The main objective of our study is to assess quantitative and qualitative changes in fecal microbiota before (D0) and 3 months after initiation of anti-TNF alpha.
Read the detailed description
The investigators propose to conduct an exploratory study, on 10 spondyloarthritis and 20 inflammatory bowel diseases patients (10 Crohn's disease and 10 ulcerative colitis (UC), in which a first anti-TNF alpha treatment is indicated. At D0 and M3, intestinal microbiota will be studied by DNA16S sequencing and qPCR, via a stool sampling. Volatile Organic Compounds (VOCs) profile will be obtained by mass spectrometry. Blood lymphocytes profile will be obtained by flux cytometry. In addition, a colonoscopy will be performed at D0 for UC patients, with an endoscopic and histological assessment. A second short colonoscopy will be performed for UC patients at M3. At each time, clinical assessment will be performed.
A mirror group of 10 spondyloarthritis and 20 inflammatory bowel diseases patients (10 Crohn's disease and 10 ulcerative colitis), in which an "all but anti-TNF alpha or biotherapy" treatment is indicated will be included to distinguish the specific effects on microbiota of anti-TNF alpha.
12 patients by group will be included at M0 by anticipating that some patients will stop their treatment between M0 and M3, and consequently will be excluded from M3 sampling and from final analysis. Final analysis will be performed on 10 patients by group.
- Conditions
- Spondyloarthritis, Crohn Disease, Ulcerative Colitis
- Being tested
- blood sample, stool samples, food questionnaire, colonoscopy, VOCs profile
- Keywords
- Microbiota, inflammatory bowel disease, inflammation, anti-TNF alpha
- Medical subject headings
- Spondylarthritis, Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
stool samplesOther
Study of the fecal microbiota
food questionnaireOther
food questionnaire on the seven days before the collection
colonoscopyOther
Only for patients with ulcerative colitis (in routine care)
VOCs profileOther
Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| Patients with anti-TNF alpha | Experimental | 12 spondyloarthritis and 24 inflammatory bowel diseases patients (12 Crohn's disease and 12 ulcerative colitis), in which a first anti-TNF alpha treatment is indicated. Receives: Other: blood sample; Other: stool samples; Other: food questionnaire; Other: colonoscopy; Other: VOCs profile |
| mirror group | Active comparator | A mirror group of 12 spondyloarthritis and 24 inflammatory bowel diseases patients (12 Crohn's disease and 12 ulcerative colitis), in which an "all but anti-TNF alpha or biotherapy" treatment is indicated will be included to distinguish the specific effects on microbiota of anti-TNF alpha. Receives: Other: blood sample; Other: stool samples; Other: food questionnaire; Other: colonoscopy; Other: VOCs profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline fecal microbiota profile by DNA 16S sequencing at 3 months
Measured: At 3 months from baseline
Secondary outcomes (7)
Clinical response for Crohn Disease
Harvey-Bradshaw score
Measured: At baseline (day 0) and at 3 months from baseline
Clinical response for ulcerative colitis (UC)
Mayo score
Measured: At baseline (day 0) and at 3 months from baseline
Clinical response for spondyloarthritis (SpA)
BASDAI or Ankylosing Spondylarthritis Disease Activity Score (ASDAS) score
Measured: At baseline (day 0) and at 3 months from baseline
Ratio of circulating Th17 / Treg lymphocytes
Measured: At baseline (day 0) and at 3 months from baseline
Only for UC group : Analysis of endoscopic activity
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
Measured: At baseline (day 0) and at 3 months from baseline
Only for UC group : Analysis of histological activity
Riley score
Measured: At baseline (day 0) and at 3 months from baseline
Change from Baseline Volatile Organic Compounds (VOCs) profile at 3 months
VOCs levels will be obtained from exhaled air samples analyzed by mass spectrometry
Measured: At baseline (day 0) and at 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start5 Jun 2018
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas BAZIN, MD, Study director, Assistance Publique - Hôpitaux de ParisRodolphe THIEBAUT, Prof, Study chair, University Hospital, BordeauxPauline RIVIERE, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359642
- Sponsor's protocol ID
- CHUBX 2017/28
- Acronym
- MIST
- Status last verified
- May 2022
- First submitted
- 10 Nov 2017
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Intestinal Microbiota in Patients With Inflammatory Bowel Disease and/or Spondyloarthritis and Study of the Impact of an Anti-TNF Alpha Therapy
- ClinicalTrials.gov ID
- NCT03359642
- Acronym / sponsor ID
- MIST / CHUBX 2017/28
- Conditions
- Spondyloarthritis, Crohn Disease, Ulcerative Colitis
- Keywords
- Microbiota, inflammatory bowel disease, inflammation, anti-TNF alpha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 2 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.
Spondyloarthritis and inflammatory bowel diseases are common diseases, frequently met together in overlap syndromes. Their physiopathology remains puzzling. A strong role of gut microbiota has been recently put forward to explain the development of inflammatory bowel diseases, and is suspected to play an important role in rheumatoid diseases. Anti-Tumor Necrosis Factor (anti-TNF) alpha are effective and safe drugs in the treatment of both digestive and rheumatoid inflammatory diseases. The way they work is unclear, and the clinical response to this treatment is variable. A better understanding of the pathophysiology of inflammatory bowel diseases and of the action of anti-TNF alpha is essential to an optimized care.
Our hypothesis is that the efficacy of anti-TNF alpha in spondyloarthritis and in inflammatory bowel diseases is at least partly due to its restoring action of homeostasis at the interface between gastrointestinal mucosa and intestinal microbiota, either by primary action on the digestive epithelium, allowing it to regain its control and tolerance functions toward mucosal microbiota, either by direct action on the intestinal microbiota, via an inter-reigns regulation.
The main objective of our study is to assess quantitative and qualitative changes in fecal microbiota before (D0) and 3 months after initiation of anti-TNF alpha.
Detailed description
The investigators propose to conduct an exploratory study, on 10 spondyloarthritis and 20 inflammatory bowel diseases patients (10 Crohn's disease and 10 ulcerative colitis (UC), in which a first anti-TNF alpha treatment is indicated. At D0 and M3, intestinal microbiota will be studied by DNA16S sequencing and qPCR, via a stool sampling. Volatile Organic Compounds (VOCs) profile will be obtained by mass spectrometry. Blood lymphocytes profile will be obtained by flux cytometry. In addition, a colonoscopy will be performed at D0 for UC patients, with an endoscopic and histological assessment. A second short colonoscopy will be performed for UC patients at M3. At each time, clinical assessment will be performed.
A mirror group of 10 spondyloarthritis and 20 inflammatory bowel diseases patients (10 Crohn's disease and 10 ulcerative colitis), in which an "all but anti-TNF alpha or biotherapy" treatment is indicated will be included to distinguish the specific effects on microbiota of anti-TNF alpha.
12 patients by group will be included at M0 by anticipating that some patients will stop their treatment between M0 and M3, and consequently will be excluded from M3 sampling and from final analysis. Final analysis will be performed on 10 patients by group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with anti-TNF alpha | Experimental | Other: blood sample, Other: stool samples, Other: food questionnaire, Other: colonoscopy, Other: VOCs profile12 spondyloarthritis and 24 inflammatory bowel diseases patients (12 Crohn's disease and 12 ulcerative colitis), in which a first anti-TNF alpha treatment is indicated. |
| mirror group | Active comparator | Other: blood sample, Other: stool samples, Other: food questionnaire, Other: colonoscopy, Other: VOCs profileA mirror group of 12 spondyloarthritis and 24 inflammatory bowel diseases patients (12 Crohn's disease and 12 ulcerative colitis), in which an "all but anti-TNF alpha or biotherapy" treatment is indicated will be included to distinguish the specific effects on microbiota of anti-TNF alpha. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged over 18 years
- Patients with the following conditions :
- Patients naïve to anti-TNF alpha, justifying the initiation of an anti-TNF alpha treatment according to current guidelines (ECCO Inflammatory bowel disease (IBD) recommendations, the recommendations of the French Society of Rheumatology for SpA)
- Patients agreeing to sign the informed consent
Key exclusion criteria (5 listed)
- Patient with an inflammatory disease other than UC, CD or SpA
- History of bowel resection or digestive stoma
- Taking antibiotics in the three months preceding the stool collection
- Patients with contraindication to treatment
- Pregnancy or breast feeding
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 sample14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Other | Patients with anti-TNF alpha, mirror group |
| stool samplesStudy of the fecal microbiota | Other | Patients with anti-TNF alpha, mirror group |
| food questionnairefood questionnaire on the seven days before the collection | Other | Patients with anti-TNF alpha, mirror group |
| colonoscopyOnly for patients with ulcerative colitis (in routine care) | Other | Patients with anti-TNF alpha, mirror group |
| VOCs profileVolatile Organic Compounds (VOCs) profile obtained by mass spectrometry | Other | Patients with anti-TNF alpha, mirror group |
Primary outcome
Change from Baseline fecal microbiota profile by DNA 16S sequencing at 3 months
Time frame: At 3 months from baseline
7 secondary outcomes
Clinical response for Crohn Disease
Time frame: At baseline (day 0) and at 3 months from baseline
Clinical response for ulcerative colitis (UC)
Time frame: At baseline (day 0) and at 3 months from baseline
Clinical response for spondyloarthritis (SpA)
Time frame: At baseline (day 0) and at 3 months from baseline
Ratio of circulating Th17 / Treg lymphocytes
Time frame: At baseline (day 0) and at 3 months from baseline
Only for UC group : Analysis of endoscopic activity
Time frame: At baseline (day 0) and at 3 months from baseline
Only for UC group : Analysis of histological activity
Time frame: At baseline (day 0) and at 3 months from baseline
Change from Baseline Volatile Organic Compounds (VOCs) profile at 3 months
Time frame: At baseline (day 0) and at 3 months from baseline
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 26 May 2022.
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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.
Thomas BAZIN, MD study director
Assistance Publique - Hôpitaux de Paris
Rodolphe THIEBAUT, Prof study chair
University Hospital, Bordeaux
Pauline RIVIERE, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample, stool samples and food questionnaire in people with Spondyloarthritis and Crohn Disease, run by University Hospital, Bordeaux 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 7 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 26 May 2022. 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?
Change from Baseline fecal microbiota profile by DNA 16S sequencing at 3 months (time frame: At 3 months from baseline). 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 26 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.