Probiotics and Sulphasalazine in the treatment of Rheumatoid Arthritis

In patients with Rheumatoid Arthritis taking Sulphasalazine, does the addition of Probiotic alter the drug's metabolism as measured in blood and urine?

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000266369

Enrollment

Registered

2008-05-26

Start date

2008-06-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results