Effects of Probiotics on Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of the present study is to examine the utility of probiotics as an adjunctive
      therapy (in addition to patients' pharmacotherapy) for the treatment of Rheumatoid Arthritis.

      We hypothesize that specifically selected probiotics, Lactobacillus rhamnosus GR-1 and L.
      reuteri RC-14, can alleviate symptoms of RA and thereby increase the daily activity of these
      patients.
    

Detailed description: 
      Patients between 18 - 80 years old who have Rheumatoid arthritis with at least 4 swollen and
      tender joints will be randomized to receive by mouth two capsules containing placebo or
      probiotic, Lactobacillus rhamnosus GR-1 and L. reuteri RC-14, daily. The subjects will
      continue to take the placebo or probiotic, in addition to their RA medications (i.e. ongoing
      medication and/or other therapy, such as physiotherapy are permitted, except immunotherapy)
      for three months.

      At day 0 (visit #1) (when recruited and just prior to starting to take capsules), at day 45
      (visit #2), and at day 90 (visit #3), blood samples of approximately 40 ml of blood (8
      teaspoons) will be collected by clinical technicians working in the Lab Test Centre at St.
      Joseph's Health Center. The blood samples will be used to evaluate Erythrocyte Sedimentation
      Rate (ESR) and C-reactive protein level. In addition, immunological markers like TNFα, IL-12,
      IL-10 and G-CSF will also be measured. Serum creatinine and liver function will be evaluated
      as parameters of any side effects of the probiotics.

      Probiotics/placebo will be dispensed from the pharmacy and provided to the subjects by the
      study investigator at the first visit (for the first 45 days) and second visit (for the final
      45 days).

      At day 0, 45 and 90 (visits 1, 2 and 3) a physical exam will be completed, where the
      physician will count the number of swollen and tender joints and complete the Physician
      Global Assessment of Disease activity. In addition, at these times, the patients will be
      asked to complete the following self-administered questionnaires:

        -  Health Assessment Questionnaire (HAQ);

        -  Patient's Global Assessment of Disease Activity

        -  Patient Assessment of Pain and Assessment of Duration of Morning stiffness.

      Patients will also be asked about feeling fatigued or sleepy, as these are standard questions
      that come with the above-mentioned questionnaires. These are simple questionnaires that will
      take approximately 15 minutes to complete. In visit 2 and 3 the physician will confirm if the
      participant is taking the study capsule/placebo correctly, review any new medications the
      patient has taken since the last visit and will ask about adverse events that may have
      occurred.

      At day 90, subjects will stop taking capsules.

      A follow-up phone call will take place 30 days after the completion of the study medication
      (day 120). If a patient is withdrawn or withdraws from the study prematurely, he/she will be
      asked to receive a follow-up telephone call 30 days from the date they last took the study
      product. During the phone call, which should not take more than 10 minutes, the participant
      will be asked about any medications taken in the past month and about any possible side
      effects (unwanted effects or health problems) that they may have experienced.
    

Intervention name(s): Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14
Intervention type(s): Dietary Supplement
Intervention description(s): 2 capsules daily for 3 months.
Other intervention name(s): Urex-CAP-5 capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Rheumatoid Arthritics; probiotics; Lactobacillus