Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000266369
Ethics application status
Approved
Date submitted
23/05/2008
Date registered
26/05/2008
Date last updated
26/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Probiotics and Sulphasalazine in the treatment of Rheumatoid Arthritis
Scientific title
In patients with Rheumatoid Arthritis taking Sulphasalazine, does the addition of Probiotic alter the drug's metabolism as measured in blood and urine?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 3181 0
Rheumatoid arthritis 3185 0
Condition category
Condition code
Inflammatory and Immune System 3342 3342 0 0
Rheumatoid arthritis
Musculoskeletal 3347 3347 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.
The probiotic 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 will take one dose of the probiotic twice daily for one week.
Intervention code [1] 2913 0
Treatment: Drugs
Comparator / control treatment
The same patients taking the probiotic will act as controls.
The same metabolite levels of Sulphasalazine will be measured prior to starting probiotic and one month after completion of probiotic to determine the alteration of its levels whilst participants are on probiotic.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4231 0
Change in levels of sulphasalazine metabolites (sulphapyridine, 5 aminosalicylic acid and sulphasalazine levels in blood and urine)
Timepoint [1] 4231 0
At baseline, one week (at completion of course of probiotics) and four weeks.
Secondary outcome [1] 7146 0
Disease activity of Rheumatoid Arthritis assessed by Disease Activity Score (DAS), which is a count of swollen and/or tender joints combined with the C-reactive protein (CRP) in mg/l- level and patient global assessment score.
Timepoint [1] 7146 0
At baseline, one week and four weeks.
Secondary outcome [2] 7147 0
Side effects of Sulphasalazine as measured by blood full blood count, liver function tests and creatinine.
Timepoint [2] 7147 0
At baseline, one week and four weeks.

Eligibility
Key inclusion criteria
Fulfillment of ACR (American College of Rheumatology) criteria of Rheumatoid Arthritis
Taking Sulphasalazine for at least 3 months
If female of reproductive age must be on effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychiatric illness - major depression, psychosis or dementia
Pregnancy or lactation
Malignancy
Current acute infection - especially Gastro-Intestinal infection
Current treatment with antibiotics
Chronic infection - HIV, hepatitis B + C, EBV, TB
Known allergy to probiotics
Sulphasalazine dose greater than 1g twice daily or 40mg/kg
Symptoms attributable to side effects of sulphasalazine
Significant renal impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Subjects are identified from a database of patients with Rheumatoid Arthritis and invited to participate.
Phase
Phase 2
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 991 0
New Zealand
State/province [1] 991 0
Otago

Funding & Sponsors
Funding source category [1] 3418 0
University
Name [1] 3418 0
Dunedin School of Medicine
Country [1] 3418 0
New Zealand
Funding source category [2] 3419 0
Commercial sector/Industry
Name [2] 3419 0
Blis Technologies Ltd,
Country [2] 3419 0
New Zealand
Primary sponsor type
University
Name
Dr. Simon Stebbings, Dunedin School of Medicine
Address
Dunedin School of Medicine,
Great King Street,
Dunedin
Country
New Zealand
Secondary sponsor category [1] 3062 0
University
Name [1] 3062 0
Dunedin School of Pharmacy
Address [1] 3062 0
Dunedin School of Pharmacy,
Great King Street,
Dunedin
Country [1] 3062 0
New Zealand
Other collaborator category [1] 293 0
Commercial sector/Industry
Name [1] 293 0
Blis Technology Ltd,
Address [1] 293 0
Centre for Innovation,
87 St. David Street,
Dunedin
Country [1] 293 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5442 0
Lower South Regional Ethics Committee
Ethics committee address [1] 5442 0
229 Moray Place,
Dunedin
Ethics committee country [1] 5442 0
Date submitted for ethics approval [1] 5442 0
Approval date [1] 5442 0
14/05/2008
Ethics approval number [1] 5442 0
LRS/08/05/017

Summary
Brief summary
Probiotics are cultures of bacteria intended to impart a beneficial effect on the host. Sulphasalazine, a drug frequently used to treat Rheumatoid Arthritis, is split into two active ingredients by the resident bacteria of the normal human gut. Preliminary evidence from animal work suggests that there would be an increase in sulphasalazine metabolites when combined with probiotics. This could alter its efficacy and side effects, which could be clinically important, especially as probiotics are now widely available and usually regarded as harmless. There is little awareness about the interactions between probiotics and conventional medications either by health professionals or the public.
We plan to carry out a pilot study of 12 patients with Rheumatoid Arthritis. Patients will have a baseline assessment of their disease in rheumatology clinic and will have blood, 24 hour urine and stool analysed for sulphasalazine and its metabolites. Subjects will then take probiotics for a week and have blood, urine and stool samples reanalysed. They will also have a clinical assessment in clinic. These tests will be repeated in a further 3 weeks after stopping probiotics. Any patient becoming unwell during the time of taking probiotics will have earlier analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28610 0
Address 28610 0
Country 28610 0
Phone 28610 0
Fax 28610 0
Email 28610 0
Contact person for public queries
Name 11767 0
Dr. Simon Stebbings
Address 11767 0
Dunedin School of Medicine,
Great King Street,
Dunedin
Country 11767 0
New Zealand
Phone 11767 0
0064 34740999
Fax 11767 0
0064 34747641
Email 11767 0
simon.stebbings@otago.ac.nz
Contact person for scientific queries
Name 2695 0
Dr. Simon Stebbings
Address 2695 0
Dunedin School of Medicine,
Great King Street,
Dunedin
Country 2695 0
New Zealand
Phone 2695 0
0064 34740999
Fax 2695 0
0064 34747641
Email 2695 0
simon.stebbings@otago.ac.nz

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
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Documents added automatically
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