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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Probiotic Preparation of Bacillus coagulans: Is It a
Viable Adjunct Therapy for Relieving Symptoms of Osteoarthritis?
Scientific title
A Randomized, Placebo-Controlled Trial of a Patented Preparation of Bacillus coagulans as Adjunct Therapy for the Relief of Symptoms in Osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild to moderate osteoarthritis 4775 0
Condition category
Condition code
Musculoskeletal 237118 237118 0 0

Study type
Description of intervention(s) / exposure
Bacillus coagulans GBI-30, 6086 is a patented strain of probiotic lactic-acid producing bacteria. It was taken in caplet form orally with water once daily for up to 60 days. Each caplet/dose contained 2 x 10 9 colony-forming units (CFUs).
Intervention code [1] 4554 0
Treatment: Drugs
Comparator / control treatment
Identically appearing placebo caplet (985 mg) containing microcrystalline cellulose was taken orally with water once daily for 60 days,
Control group

Primary outcome [1] 237945 0
Measures of functional capacity and symptom severity of osteoarthritis affecting the knee or back. Patients were assessed at baseline, 30 days, and 60 days from the start of treatment using the Knee Injury and Osteoarthritis Outcome Scale (KOOS) or the Oswestry Disability Questionnaire.
Timepoint [1] 237945 0
60 days following the commencement of treatment.
Secondary outcome [1] 242040 0
Safety. Adverse events such as gas, cramps, or diarrhea were reported directly to each investigator.
Timepoint [1] 242040 0
60 days following the commencement of treatment.

Key inclusion criteria
Adult men and women with a documented history of mild to moderate osteoarthritis for at least 12 months and had not started any new therpay within the last 3 months
Minimum age
18 Years
Maximum age
64 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Women of child bearing age, current probiotic usage, antibiotic therapy over the last 2 weeks, no new therapy within the last 3 months, kidney and liver disease

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 1760 0
United States of America
State/province [1] 1760 0

Funding & Sponsors
Funding source category [1] 4957 0
Commercial sector/Industry
Name [1] 4957 0
Ganeden Biotech Inc.
Address [1] 4957 0
5915 Landerbrook Dr. Suite 304
Mayfield Heights, OH 44124
Country [1] 4957 0
United States of America
Primary sponsor type
Keith Lamberson, MD
Pinnacle Orthopedics & Sports Medicine Specialists
1668 Mulkey Road
Austell, GA 30106
United States of America
Secondary sponsor category [1] 4476 0
Name [1] 4476 0
Address [1] 4476 0
Country [1] 4476 0

Ethics approval
Ethics application status
Ethics committee name [1] 7055 0
Sterling Institutional Review Board (Atlanta, GA)
Ethics committee address [1] 7055 0
Ethics committee country [1] 7055 0
Date submitted for ethics approval [1] 7055 0
Approval date [1] 7055 0
Ethics approval number [1] 7055 0

Brief summary
Certain probiotics have demonstrated the ability to lessen the symptoms of arthritis in animals and humans. This clinical trial was conducted to evaluate the effects of the probiotic Bacillus coagulan GBI-30, 6086 as adjunct therapy for the relief of symptoms of mild to moderate osteoarthritis.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29606 0
Address 29606 0
Country 29606 0
Phone 29606 0
Fax 29606 0
Email 29606 0
Contact person for public queries
Name 12853 0
Keith Lamberson, MD
Address 12853 0
Pinnacle Orthopedics & Sports Medicine Specialists
1668 Mulkey Road
Austell, GA 30106
Country 12853 0
United States of America
Phone 12853 0
Fax 12853 0
Email 12853 0
Contact person for scientific queries
Name 3781 0
Keith Lamberson, MD
Address 3781 0
Pinnacle Orthopedics & Sports Medicine Specialists
1668 Mulkey Road
Austell, GA 30106
Country 3781 0
United States of America
Phone 3781 0
Fax 3781 0
Email 3781 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary