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

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 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.

Conditions

• Spondyloarthritis
• Crohn Disease
• Ulcerative Colitis

Interventions

OTHER

blood sample

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

OTHER

stool samples

Study of the fecal microbiota

OTHER

food questionnaire

food questionnaire on the seven days before the collection

OTHER

colonoscopy

Only for patients with ulcerative colitis (in routine care)

OTHER

VOCs profile

Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry

Sponsors & Collaborators

• University Hospital, Bordeaux

  lead OTHER

Principal Investigators

• Thomas BAZIN, MD · Assistance Publique - Hôpitaux de Paris

• Rodolphe THIEBAUT, Prof · University Hospital, Bordeaux

• Pauline RIVIERE, MD · University Hospital, Bordeaux

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-05

Primary Completion

2021-09-16

Completion

2021-09-16

Countries

• France

Study Locations