| Summary: | <p>Abstract</p> <p>Background</p> <p>Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, <it>Bacillus coagulans </it>GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications.</p> <p>Methods</p> <p>Forty-five adult men and women with symptoms of RA were randomly assigned to receive <it>Bacillus coagulans </it>GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).</p> <p>Results</p> <p>Subjects who received <it>Bacillus coagulans </it>GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (<it>P </it>= .052) and statistically significant improvement in Pain Scale (<it>P </it>= .046) vs placebo. Compared with placebo, <it>Bacillus coagulans </it>GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study.</p> <p>Conclusions</p> <p>Results of this pilot study suggest that adjunctive treatment with <it>Bacillus coagulans </it>GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results.</p> <p>Trial registration</p> <p>ACTRN12609000435280</p>
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