RESEARCH ARTICLEOpen Access
Bacillus coagulans: a viable adjunct therapy for
relieving symptoms of rheumatoid arthritis
according to a randomized, controlled trial
David R Mandel1*, Katy Eichas2, Judith Holmes1
Background: 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, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional
capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications.
Methods: Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus
coagulans 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).
Results: Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant
improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale
(P = .046) vs placebo. Compared with placebo, Bacillus coagulans 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.
Conclusions: Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans 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.
Trial registration: ACTRN12609000435280
Probiotics have been used to treat and prevent a wide
range of infectious and inflammatory diseases [1,2]. Of
particular interest are lactic acid bacteria (LAB) probio-
tics and their immunomodulating and anti-inflammatory
effects, which have been shown to lessen the symptoms
of arthritis [3-8].
Rheumatoid arthritis (RA) affects more than 1.3 mil-
lion American adults . It commonly leads to signifi-
cant disability and compromises quality of life.
Pharmacological treatments for arthritis target the
inflammatory process by suppressing the host reaction.
Despite the number of effective pharmacological agents
available today, a substantial proportion of patients will
experience persistent, low-level disease activity .
This underscores the need for adjunctive therapies that
are safe and can help relieve the painful symptoms of
RA is an autoimmune disorder in which unchecked
immune and inflammatory responses cause articular
pain and eventually cartilage degradation and bone
destruction . Disease develops when there is an
imbalance in the cytokine network, either from excess
production of pro-inflammatory cytokines or from
* Correspondence: email@example.com
1David R. Mandel, MD, Inc., Mayfield Village, OH 44143, USA
Mandel et al. BMC Complementary and Alternative Medicine 2010, 10:1
© 2010 Mandel et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons
Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
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Cite this article as: Mandel et al.: Bacillus coagulans: a viable adjunct
therapy for relieving symptoms of rheumatoid arthritis according to a
randomized, controlled trial. BMC Complementary and Alternative Medicine
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