Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000144314
Ethics application status
Approved
Date submitted
7/03/2008
Date registered
20/03/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a Culture of Healthy Bacteria be used to Treat Arthritis?
Scientific title
A Double Blind Randomised Controlled Trial of an Orally administered Probiotic in the Treatment of Spondyloarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondyloarthritis 2913 0
Condition category
Condition code
Musculoskeletal 3048 3048 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2645 0
Treatment: Other
Comparator / control treatment
Subjects with spondyloarthrits receiving Placebo (trehalose, maltodextrin and vanilla flavour).
Control group
Placebo

Outcomes
Primary outcome [1] 3930 0
European League Against Rheumatism (EULAR) Assesments in Ankylosing Spondylitis (ASAS) response criteria for Ankylosing spondylitis intervention trials
Timepoint [1] 3930 0
0, 1, 3, 4 months
Secondary outcome [1] 6612 0
Bath Ankylosing spondylitis disease activity index (BASDAI)
Timepoint [1] 6612 0
0, 1 , 3, 4 months
Secondary outcome [2] 6681 0
Bath Ankylosing spondylitis functional index (BASFI)
Timepoint [2] 6681 0
0, 1 , 3, 4 months
Secondary outcome [3] 6682 0
Bath Ankylosing spondylitis metrology index (BASMI)
Timepoint [3] 6682 0
0, 3, 4 months
Secondary outcome [4] 6683 0
Bath Ankylosing spondylitis patient global score (BASG)
Timepoint [4] 6683 0
0, 1 , 3, 4 months
Secondary outcome [5] 6684 0
Peripheral tender and swollen joint count
Timepoint [5] 6684 0
0, 1 , 3, 4 months
Secondary outcome [6] 6685 0
Maastricht Ankylosing Spondylitis Enthesitis score (MASES) enthesitis index
Timepoint [6] 6685 0
0, 1 , 3, 4 months
Secondary outcome [7] 6686 0
C-reactive protein (CRP)
Timepoint [7] 6686 0
0, 1 , 3, 4 months
Secondary outcome [8] 6687 0
Multidimensional assesment of fatigue (MAF) index
Timepoint [8] 6687 0
0, 3, 4 months
Secondary outcome [9] 6688 0
Ankylosing spondylitis Quality of Life (ASQol) assesment
Timepoint [9] 6688 0
0, 1 , 3, 4 months

Eligibility
Key inclusion criteria
Modified New York criteria for Ankylosing spondylitis OR European Spondyloarthropathy study group (ESSG) criteria for spondyloarthritis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, severe immunosupression, active inflammatory bowel disease, current gastrointestinal infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are identified from a database of patients with spondyloarthritis and invited to participate. Subjects are randomised using random number generation by Clinical trials manager at BLIS technologies. Assessment and enrolment are performed by blinded assessor who allocates the coded probiotic. Codes are held by clinical trials manager who is not involved in the assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 816 0
New Zealand
State/province [1] 816 0
Otago

Funding & Sponsors
Funding source category [1] 3166 0
Charities/Societies/Foundations
Name [1] 3166 0
Arthritis New Zealand
Country [1] 3166 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Great King Street
Dunedin
Country
New Zealand
Secondary sponsor category [1] 2840 0
Commercial sector/Industry
Name [1] 2840 0
Bacteriocin Like Inhibitory Substances (BLIS) Technologies
Address [1] 2840 0
Center for Innovation
University of Otago
87 St David Street
Dunedin
Country [1] 2840 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5146 0
Lower South Regional Ethics Committee
Ethics committee address [1] 5146 0
Ministry of Health
229 Moray Place
PO Box 5849
Dunedin
Ethics committee country [1] 5146 0
New Zealand
Date submitted for ethics approval [1] 5146 0
Approval date [1] 5146 0
Ethics approval number [1] 5146 0
LRS/06/02/008

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28429 0
Address 28429 0
Country 28429 0
Phone 28429 0
Fax 28429 0
Email 28429 0
Contact person for public queries
Name 11586 0
Dr Simon Stebbings
Address 11586 0
Department of Medical and Surgical Sciences
Dunedin School of Medicine
Great King Street
Dunedin
Country 11586 0
New Zealand
Phone 11586 0
+ 64 3 4740999
Fax 11586 0
+ 64 3 4747641
Email 11586 0
[email protected]
Contact person for scientific queries
Name 2514 0
Dr Simon Stebbings
Address 2514 0
Dunedin School of Medicine
Great King Street
Dunedin
Country 2514 0
New Zealand
Phone 2514 0
+ 64 3 4740999
Fax 2514 0
Email 2514 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.