Crohn DiseaseFLORACROHNNCT03072836
Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
A study testing analysing microbiota in people with Crohn Disease and Spondyloarthritis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Spondyloarthritis
- What is being tested?
- analysing microbiota
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2017to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy, 54511
Laurent PEYRIN-BIROULET, MD, PHD, 03 83 15 36 61, l.peyrin-biroulet@chu-nancy.fr
About this study
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.
- Conditions
- Crohn Disease, Spondyloarthritis
- Being tested
- analysing microbiota
- Medical subject headings
- Crohn Disease, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysing microbiotaOther
16SRNA gene sequencing of feces
| Study group | Role | What they receive |
|---|---|---|
| CD alone | Experimental | Not described Receives: Other: analysing microbiota |
| SPA alone | Experimental | Not described Receives: Other: analysing microbiota |
| CD + SPA | Experimental | Not described Receives: Other: analysing microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota analysis
16SRNA gene sequencing
Measured: 6 months after last patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start6 Mar 2017
- Primary completion15 May 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Laurent PEYRIN BIROULET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072836
- Sponsor's protocol ID
- 2016-A01720-51
- Acronym
- FLORACROHN
- Status last verified
- Jan 2020
- First submitted
- 2 Mar 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis
- ClinicalTrials.gov ID
- NCT03072836
- Acronym / sponsor ID
- FLORACROHN / 2016-A01720-51
- Conditions
- Crohn Disease, Spondyloarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CD alone | Experimental | Other: analysing microbiota |
| SPA alone | Experimental | Other: analysing microbiota |
| CD + SPA | Experimental | Other: analysing microbiota |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
- Patient with the capacity to give free and informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysing microbiota16SRNA gene sequencing of feces | Other | CD + SPA, CD alone, SPA alone |
Primary outcome
Microbiota analysis
Time frame: 6 months after last patient inclusion
16SRNA gene sequencing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analysing microbiota in people with Crohn Disease and Spondyloarthritis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota analysis (time frame: 6 months after last patient inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.