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NCT Number: NCT03359642

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

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.

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylarthritis Spondylitis Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - service d'Hépato-gastroentérologie

Pessac, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

blood sample

Other

14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Stool samples

Other

Study of the fecal microbiota

food questionnaire

Other

food questionnaire on the seven days before the collection

colonoscopy

Other

Only for patients with ulcerative colitis (in routine care)

VOCs profile

Other

Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry

Primary outcomes

  1. Change from Baseline fecal microbiota profile by DNA 16S sequencing at 3 months

    Time frame: At 3 months from baseline

Secondary outcomes

  1. Clinical response for Crohn Disease

    Time frame: At baseline (day 0) and at 3 months from baseline

    Harvey-Bradshaw score

  2. Clinical response for ulcerative colitis (UC)

    Time frame: At baseline (day 0) and at 3 months from baseline

    Mayo score

  3. Clinical response for spondyloarthritis (SpA)

    Time frame: At baseline (day 0) and at 3 months from baseline

    BASDAI or Ankylosing Spondylarthritis Disease Activity Score (ASDAS) score

  4. Ratio of circulating Th17 / Treg lymphocytes

    Time frame: At baseline (day 0) and at 3 months from baseline

  5. Only for UC group : Analysis of endoscopic activity

    Time frame: At baseline (day 0) and at 3 months from baseline

    Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score

  6. Only for UC group : Analysis of histological activity

    Time frame: At baseline (day 0) and at 3 months from baseline

    Riley score

  7. Change from Baseline Volatile Organic Compounds (VOCs) profile at 3 months

    Time frame: At baseline (day 0) and at 3 months from baseline

    VOCs levels will be obtained from exhaled air samples analyzed by mass spectrometry

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: MIST

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2017
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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