Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000441213
Ethics application status
Approved
Date submitted
14/05/2009
Date registered
12/06/2009
Date last updated
12/06/2009
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
Osteoarthritis

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
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.
Country [1] 4957 0
United States of America
Primary sponsor type
Individual
Name
Keith Lamberson, MD
Address
Pinnacle Orthopedics & Sports Medicine Specialists
1668 Mulkey Road
Austell, GA 30106
Country
United States of America
Secondary sponsor category [1] 4476 0
None
Name [1] 4476 0
Address [1] 4476 0
Country [1] 4476 0

Ethics approval
Ethics application status
Approved
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

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
1-770-944-3303
Fax 12853 0
Email 12853 0
keithlamberson@msn.com
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
1-770-944-3303
Fax 3781 0
Email 3781 0
keithlamberson@msn.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.