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Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy (MEDIBIOTE 3)

Primary Purpose

Spondyloarthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
stool sampling
stool sampling
Sponsored by
Hôpital Européen Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spondyloarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For patient with spondyloarthritis:

  • Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria.
  • Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR)
  • patient not previously treated with biotherapy
  • Aged ≥ 18 years
  • Having given free and informed written consent
  • Being affiliated to the center national security system social

For control Subject:

  • Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease.
  • Aged ≥ 18 years
  • Having given free and informed written consent
  • Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

  • Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling.
  • Association with another chronic pathology

Sites / Locations

  • Hôpital Européen MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with spondyloarthritis (Spa)

Healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients

Secondary Outcome Measures

Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.

Full Information

First Posted
May 19, 2021
Last Updated
May 26, 2021
Sponsor
Hôpital Européen Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04899154
Brief Title
Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Acronym
MEDIBIOTE 3
Official Title
MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital Européen Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated. Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota. The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with spondyloarthritis (Spa)
Arm Type
Experimental
Arm Title
Healthy subjects
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
stool sampling
Intervention Description
Participants will provide two stool samples: one collected the day of inclusion and a second, four months later after anti-TNF α or anti- IL-17 (interleukin-17) treatment initiation.
Intervention Type
Other
Intervention Name(s)
stool sampling
Intervention Description
Participants will provide one stool sample at inclusion
Primary Outcome Measure Information:
Title
Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.
Time Frame
18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For patient with spondyloarthritis: Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria. Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR) patient not previously treated with biotherapy Aged ≥ 18 years Having given free and informed written consent Being affiliated to the center national security system social For control Subject: Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease. Aged ≥ 18 years Having given free and informed written consent Being affiliated with or benefiting from a social security scheme. Exclusion Criteria: Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling. Association with another chronic pathology
Facility Information:
Facility Name
Hôpital Européen Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam BENNANI
Phone
04 13 42 83 51
Email
m.bennani@hopital-europeen.fr
First Name & Middle Initial & Last Name & Degree
Caroline CHARPIN, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

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