NCT03072836

Brief Summary

The FLORACROHN project aims to compare gut microbiota of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. Fecal microbiota will be determined by 16SRNA gene sequencing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

3.2 years

First QC Date

March 2, 2017

Last Update Submit

January 22, 2020

Conditions

Crohn DiseaseSpondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • Microbiota analysis

    16SRNA gene sequencing

    6 months after last patient inclusion

Study Arms (3)

CD alone

EXPERIMENTAL
Other: analysing microbiota

SPA alone

EXPERIMENTAL
Other: analysing microbiota

CD + SPA

EXPERIMENTAL
Other: analysing microbiota

Interventions

analysing microbiotaOTHER

16SRNA gene sequencing of feces

CD + SPACD aloneSPA alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
  • Patient with the capacity to give free and informed consent.

You may not qualify if:

  • Antecedent of colonic resection
  • Antibiotic or colonic colonoscopy preparation in the 8 weeks prior to stool collection (against temporary indication = collection possible before colic preparation or on the first saddle after the start of the colic preparation).
  • Ostomy at time of collection
  • BMI\> 30
  • extreme diet
  • unbalanced diabetes
  • Patient under guardianship, under curatorship or under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseSpondylarthritis

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 7, 2017

Study Start

March 6, 2017

Primary Completion

May 15, 2020

Study Completion

December 15, 2020

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)