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Trial registered on ANZCTR


Registration number
ACTRN12609000435280
Ethics application status
Approved
Date submitted
22/05/2009
Date registered
11/06/2009
Date last updated
12/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is a Patented Strain of Bacillus coagulans Probiotic a Viable Adjunct Therapy for Relieving Symptoms of Rheumatoid Arthritis?
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of Bacillus coagulans as Adjunct Therapy for the Relief of Symptoms of Rheumatoid Arthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rheumatoid arthritis 4833 0
Condition category
Condition code
Musculoskeletal 237176 237176 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patented strain of Bacillus coagulans probiotic in caplet form taken orally with water once daily for 60 days. Each caplet/dose contains 2 x 10 9 colony-forming units (CFUs).
Intervention code [1] 4612 0
Treatment: Drugs
Comparator / control treatment
Identical appearing placebo caplets (985 mg) containing microcrystalline cellulose were taken orally with water once daily for 60 days.
Control group
Placebo

Outcomes
Primary outcome [1] 238111 0
Pain assessment score and pain scale. American College of Rheumatology (ACR) questionnaire and Health Assessment Questionnaire (HAQ) were used to assess symptom severity compared with baseline self-assessment scores. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were used to assess change in inflammation.
Timepoint [1] 238111 0
60 days following the commencement of treatment.
Secondary outcome [1] 242324 0
Functional ability and safety. The Health Assessment Questionnaire (HAQ) was used to assess the ability to arise, walk 2 miles, perform daily activities, dress and groom, eat, reach, grip, and maintain personal hygiene.
Timepoint [1] 242324 0
60 days following the commencement of treatment.

Eligibility
Key inclusion criteria
Subjects were diagnosed with rheumatoid arthritis at least a year prior to the study
Minimum age
36 Years
Maximum age
82 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, chronic inflammatory bowel disease, kidney or liver disease, and subjects taking >10 mg/day of prednislone or other probiotic products

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1800 0
United States of America
State/province [1] 1800 0

Funding & Sponsors
Funding source category [1] 237126 0
Commercial sector/Industry
Name [1] 237126 0
Ganeden Biotech, Inc.
Address [1] 237126 0
5915 Landerbrook Dr., Suite 304
Mayfield Heights, OH 44124
Country [1] 237126 0
United States of America
Primary sponsor type
Individual
Name
David R. Mandel, MD
Address
David R. Mandel, MD, Inc.
6551 Wilson Mills Rd, #106
Mayfield Village, OH 44143
Country
United States of America
Secondary sponsor category [1] 4516 0
None
Name [1] 4516 0
Address [1] 4516 0
Country [1] 4516 0

Ethics approval
Ethics application status
Approved

Summary
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 on symptoms and functional capacity in patients with rheumatoid arthritis when taken in combination with pharmacological anti-arthritic medications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29632 0
Address 29632 0
Country 29632 0
Phone 29632 0
Fax 29632 0
Email 29632 0
Contact person for public queries
Name 12879 0
David R. Mandel, MD
Address 12879 0
David R. Mandel, MD, Inc.
6551 Wilson Mills Rd, #106
Mayfield Village, OH 44143
Country 12879 0
United States of America
Phone 12879 0
1-440-449-8277
Fax 12879 0
Email 12879 0
katy@mandelmd.com
Contact person for scientific queries
Name 3807 0
David R. Mandel, MD
Address 3807 0
David R. Mandel, MD, Inc.
6551 Wilson Mills Rd, #106
Mayfield Village, OH 44143
Country 3807 0
United States of America
Phone 3807 0
1-440-449-8277
Fax 3807 0
Email 3807 0
katy@mandelmd.com

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