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
NCT ID: NCT03359642
Last Updated: 2022-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2018-06-05
2021-09-16
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients with anti-TNF alpha
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.
blood sample
14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
stool samples
Study of the fecal microbiota
food questionnaire
food questionnaire on the seven days before the collection
colonoscopy
Only for patients with ulcerative colitis (in routine care)
VOCs profile
Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry
mirror group
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.
blood sample
14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
stool samples
Study of the fecal microbiota
food questionnaire
food questionnaire on the seven days before the collection
colonoscopy
Only for patients with ulcerative colitis (in routine care)
VOCs profile
Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry
Interventions
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blood sample
14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
stool samples
Study of the fecal microbiota
food questionnaire
food questionnaire on the seven days before the collection
colonoscopy
Only for patients with ulcerative colitis (in routine care)
VOCs profile
Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Thomas BAZIN, MD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Rodolphe THIEBAUT, Prof
Role: STUDY_CHAIR
University Hospital, Bordeaux
Pauline RIVIERE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU de Bordeaux - service d'Hépato-gastroentérologie
Pessac, , France
Countries
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Other Identifiers
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CHUBX 2017/28
Identifier Type: -
Identifier Source: org_study_id
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