Hand osteoarthritis
Conditions
Interventions
Sustained Release Calcium Butyrate (SRCaBu)
Sponsors
BirrBeheer B.V.
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age = 50 year and = 75 years, - Hand OA according to the 1990 ACR diagnostic criteria for hand OA (31) in both hands operationalized as: • Hand pain, aching, or stifness and 3 or 4 of the following: o Hard tissue enlargement of 2 or more of 10 selected joints (Ten selected joints include bilateral second and third interphalangeal proximal joints, second and third distal interphalangeal joints, and first carpometacarpal joint) o Hard tissue enlargement of 2 or more DIP joints o Fewer than 3 swollen MCP joints o Deformity of at least 2 of 10 selected joints. - Pain (NRS) during hand activities of both hands = 5 = 8 (scale 0-10), during 15 of the last 30 days. - Body Mass Index (BMI) > 20 and < 30 kg/m2, - In possession of a smart phone to use the app to assess stool behaviour on a daily basis - Can operate a computer to fill in online questionnaires via CastorEDC. - Able to read, write and sufficiently communicate in Dutch - Have an email address
Exclusion criteria
Exclusion criteria: - Recent use of antibiotics (last three months) - Previous surgery of one of the hands - Recent cerebro- or cardiovascular incident (past 6 months) - Diabetes - Other chronic inflammatory disease - Other musculoskeletal diseases than OA with possible hand localisation - Cognitive deficits affecting the scoring process - Received intramuscular of intra-articular corticosteroid injections in the previous 4 weeks - Fibromyalgia according to the 2010 ACR diagnostic criteria for fibromyalgia (32) - Any other syndrome(s) or condition(s) that could interfere with the assessment of pain - Severe current psychiatric disorders assessed by physician - Self-reported consumption of alcoholic drinks, > 2 units per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in compositional and functional microbiome parameters after 4 weeks of SRCaBu treatment. A positive treatment effect with respect to microbiome composition and function is an increase in alpha diversity and fraction of strict anaerobes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Barrier function the intestine. Variables related to systemic inflammation. Variables related to immune tolerance and inflammatory response. Joint score Pain at rest (NRS) Patients' global assessment Quality of life Stool behaviour Hand function, activities of daily living, pain, work performance, aestehtics, and patient satisfaction. Blinding success | — |
Contacts
Public ContactTim Pelle
Sint Maartenskliniek
Outcome results
None listed