None listed
Conditions
Brief summary
We propose a trial of a potential treatment for Spondyloarthritis - a common form of arthritis in New Zealand which particularly affects young adults. We will use a probiotic agent (a culture of healthy bacteria) which can modify the bacterial environment in the human intestinal tract. We have previously demonstrated a disturbed bowel bacterial flora in patients with spondyloarthritis, who are known to have an inflamed ‘leaky gut’. By using a probiotic we hope to reverse the inflammatory process in the gut and improve the resulting arthritis. This is a novel approach, using a product developed by a local biotechnology company, which is a safe and potentially effective therapy.
Interventions
Trial intervention is a Probiotic provided by BLIS Technologies Dunedin.
Probiotic on trial is a preparation of live bacteria in powdered form containing 100 million Streptococcus salivarius K12, 400 million Lactobacillus acidophilus L10, 400 million Bifidobacterium Lactis B94 per dose. Each participant in the active group takes 2 small teaspoons daily for 3 months.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Modified New York criteria for Ankylosing spondylitis OR European Spondyloarthropathy study group (ESSG) criteria for spondyloarthritis
Exclusion criteria
Pregnancy, severe immunosupression, active inflammatory bowel disease, current gastrointestinal infection
Outcome results
None listed