Role of the intestine on osteoarthritis of the hand and the effect of Sustained Release Calcium Butyrate (SRCaBu)

BirrBeheer B.V.0 个研究点目标入组 33 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•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:
•oHard 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)
•oHard tissue enlargement of 2 or more DIP joints
•oFewer than 3 swollen MCP joints
•oDeformity 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

•-Recent use of antibiotics (last three months)
•-Previous surgery of one of the hands
•-Recent cerebro- or cardiovascular incident (past 6 months)
•-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

发起方

BirrBeheer B.V.