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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	18 March 2024
Main ID:	NCT03839862
Date of registration:	11/02/2019
Prospective Registration:	No
Primary sponsor:	Region Skane
Public title:	Faecal Analyses in Spondyloarthritis Therapy FAST
Scientific title:	Faecal Analyses in Spondyloarthritis Therapy: A Prospective Observational Study of the Intestinal Microbiome in Patients With Spondyloarthropathy Receiving TNF-inhibition.
Date of first enrolment:	January 1, 2019
Target sample size:	50
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03839862
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Sweden

Contacts

Name:	Kristofer Andréasson, MD PhD
Address:
Telephone:	+4646172153
Email:	kristofer.andreasson@med.lu.se
Affiliation:

Name:	Kristofer Andréasson, MD PhD
Address:
Telephone:	+4646171000
Email:	kristofer.andreasson@med.lu.se
Affiliation:

Name:	Kristofer Andréasson, MD PhD
Address:
Telephone:
Email:
Affiliation:	Lund University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Fulfilling the Assessment of SpondyloArthritis International Society classification
criteria for spondyloarthropathy.

- About to commence treatment with TNF-inhibition

Exclusion Criteria:

- Failure to understand protocol

- A history of alcohol abuse

- Any history of diverticulitis

- A history of failure to comply with prescribed medication

- Ongoing biological therapy

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Spondyloarthropathies

Intervention(s)

Drug: TNF-inhibition

Primary Outcome(s)

Change in disease activity/treatment response at follow up [Time Frame: Change from baseline BASDAI at 6 months]

Change in gut flora [Time Frame: Change from baseline Dysbiosis Index Score at 6 months]

Secondary Outcome(s)

Intestinal gut flora in spondyloarthropathies [Time Frame: Analysis made at study start /baseline]

Intestinal gut inflammation [Time Frame: Analysis made at study start /baseline]

Adherence to immunosuppressive therapy [Time Frame: Analysis made at 6 months follow up]

Secondary ID(s)

FAST1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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