An interventional study of blood sample and stool samples in Spondyloarthritis, Crohn Disease and Ulcerative Colitis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
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.
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.
202 studies on the registry are indexed under Spondylarthritis; 51 are open to participants now.
This study's enrollment of 23 is below the median of 107 across 105 interventional studies indexed under Spondylarthritis.
Browse Spondylarthritis studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Patients with the following conditions :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: blood sample · Other: stool samples · Other: food questionnaire · Other: colonoscopy · Other: VOCs profile
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.
Other: blood sample · Other: stool samples · Other: food questionnaire · Other: colonoscopy · Other: VOCs profile
14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Study of the fecal microbiota
food questionnaire on the seven days before the collection
Only for patients with ulcerative colitis (in routine care)
Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry
Change from Baseline fecal microbiota profile by DNA 16S sequencing at 3 months
Time frame: At 3 months from baseline
Clinical response for Crohn Disease
Harvey-Bradshaw score
Time frame: At baseline (day 0) and at 3 months from baseline
Clinical response for ulcerative colitis (UC)
Mayo score
Time frame: At baseline (day 0) and at 3 months from baseline
Clinical response for spondyloarthritis (SpA)
BASDAI or Ankylosing Spondylarthritis Disease Activity Score (ASDAS) score
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
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
Time frame: At baseline (day 0) and at 3 months from baseline
Only for UC group : Analysis of histological activity
Riley score
Time frame: 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
Time frame: At baseline (day 0) and at 3 months from baseline
Ran from Jun 2018 to primary completion in Sep 2021, 39 months.
Of 44 non-industry interventional studies with no phase under Spondylarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 77. This study's 39 months is above that.
Counting every sponsor, half of 46 studies reached it within 30 months; a quarter within 16 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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