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

NCT03359642 | Completed

• 1 other identifier: CHUBX 2017/28
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiota; inflammatory bowel disease; inflammation; anti-TNF alpha

Outcome Measures

Primary Outcomes (1)

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

  At 3 months from baseline

Secondary Outcomes (7)

• Clinical response for Crohn Disease

  At baseline (day 0) and at 3 months from baseline

• Clinical response for ulcerative colitis (UC)

  At baseline (day 0) and at 3 months from baseline

• Clinical response for spondyloarthritis (SpA)

  At baseline (day 0) and at 3 months from baseline

• Ratio of circulating Th17 / Treg lymphocytes

  At baseline (day 0) and at 3 months from baseline

• Only for UC group : Analysis of endoscopic activity

  At baseline (day 0) and at 3 months from baseline

Study Arms (2)

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.

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.

Other: blood sample; Other: stool samples; Other: food questionnaire; Other: colonoscopy; Other: VOCs profile

Interventions

blood sample OTHER

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

Patients with anti-TNF alpha; mirror group

stool samples OTHER

Study of the fecal microbiota

Patients with anti-TNF alpha; mirror group

food questionnaire OTHER

food questionnaire on the seven days before the collection

Patients with anti-TNF alpha; mirror group

colonoscopy OTHER

Only for patients with ulcerative colitis (in routine care)

Patients with anti-TNF alpha; mirror group

VOCs profile OTHER

Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry

Patients with anti-TNF alpha; mirror group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - service d'Hépato-gastroentérologie

Pessac, France

Location

MeSH Terms

Conditions

Spondylarthritis; Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases; Inflammation

Interventions

Blood Specimen Collection; Colonoscopy

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Thomas BAZIN, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Rodolphe THIEBAUT, Prof

  University Hospital, Bordeaux

  STUDY CHAIR

• Pauline RIVIERE, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: December 2, 2017
• Study Start: June 5, 2018
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

FR (1)