Study of Gut Microbiota in Crohn's Disease Patients Suffe... | NCT03072836

Studies
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis

NCT03072836

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Jan 23, 2020Actual

Enrollment

108Estimated

Phase

Not Applicable

Conditions

Crohn Disease
Spondyloarthritis

Interventions

analysing microbiota

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2017Actual

Primary Completion Date

May 15, 2020Estimated

Completion Date

Dec 15, 2020Estimated

First Submitted Date

Mar 2, 2017

First Submission Date that Met QC Criteria

Mar 2, 2017

First Posted Date

Mar 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2020

Last Update Posted Date

Jan 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
CD alone	Experimental	Other: analysing microbiota
SPA alone	Experimental	Other: analysing microbiota
CD + SPA	Experimental	Other: analysing microbiota

Interventions

Name	Type	Description	Arm Group Labels	Other Names
analysing microbiota	Other	16SRNA gene sequencing of feces	CD + SPA CD alone SPA alone

Measure	Description	Time Frame
Microbiota analysis	16SRNA gene sequencing	6 months after last patient inclusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- Patients with Crohn's disease (CT patients) diagnosed according to clinical, biological, radiological, endoscopic and / or histological criteria for 3 months. With diagnosis of spondyloarthritis exclusion on modified ASAS and / or New York criteria.
- Patients with axial spondyloarthritis (SpA patients) diagnosed according to the modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
Patient with the capacity to give free and informed consent.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Nancy	Recruiting	Vandœuvre-lès-Nancy		54511	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D025241	Spondylarthritis

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided