Status:
UNKNOWN
Effect of a Low Starch Diet in Patients With Ankylosing Spondylitis
Lead Sponsor:
Universidade do Porto
Collaborating Sponsors:
Portuguese Institute of Rheumatology
Centro de Investigação Interdisciplinar Egas Moniz
Conditions:
Spondyloarthritis
Ankylosing Spondylitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to explore the effect of a low starch diet (reduction of at least 40%) in the gut bacteria modulation, especially Klebsiella pneumoniae, and its relation to disease activity, ...
Detailed Description
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease characterized by axial inflammation and with unknown aetiology. The immune system dysregulation is known, where genetic factors ...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years old
- Available to comply with study protocol
- Ability to read and sign the Informed Consent
- Diagnosis of Ankylosing Spondylitis performed by the rheumatologist, according to the ASAS classification criteria, revised in 2016
- Positive HLA-B27allele
- Stable dose therapy within 3 months before selection
Exclusion
- Pregnant, breastfeeding or planning to become pregnant within the study period
- Prior or current clinical history of drug or other substances abuse
- Subjects with uncontrolled clinical conditions, like neoplastic diseases, renal failure, liver impairment, uncompensated cardiac disease
- Dietetic restrictions due to religious believes or others incompatible with the study protocol
- Impossibility to attend to the mandatory personal clinical evaluation
- Presence of pacemaker, making impossible to perform the impedance body composition analysis
- Change in therapy during the intervention period
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04386538
Start Date
January 3 2022
End Date
December 30 2022
Last Update
January 25 2022
Active Locations (1)
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1
Instituto Português de Reumatologia
Lisbon, Portugal