A series of N-of-1 trials to assess the efficacy of a probiotic supplement in pain associated with osteoarthritis

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Osteoarthritis (OA) is degenerative disease effecting joints and is characterized by articular cartilage remodeling. It is one of the most common musculoskeletal disorders worldwide and affects an estimated 15% of Australians (3 million people) (Glyn-Jones et al., 2015). OA causes pain and eventual disability, and while not usually considered an inflammatory condition, there is associated inflammation of synovial tissue (Benito et al., 2005). The complex nature of the symbiotic relationship between the gastrointestinal microflora or microbiome and the health of the host has been elucidated in recent years. An unbalanced microbiome, dominated by certain species increases the risk of diverse systemic diseases, and inflammation, often low grade and chronic, is a common factor in many of these conditions. Evidence from animal and human trials suggest probiotics may be able to positively impact bone metabolism, reduce inflammation and pain attenuating inflammation via improving muscosal barrier health (Collins et al, 2015, Lei et al., 2014)) (Lei, 2014). The project aims to assess whether a three week course of probiotics is effective for reducing the pain associated with osteoarthritis in two participants diagnosed with osteoarthritis.This is an N-of-1 series, consisting of two double-blind placebo-controlled N-of-1 trials in otherwise healthy individuals. Each trial incorporates 3 randomised blocks, each consisting of 2 X 3-week period, which may comprise either the active or placebo supplement, designated A or B . Between each period there is a 2-week washout period. The primary outcome is self-reported pain, as measured by a 100mm Visual Analogue Scale. Secondary outcomes include the Patient Specific Functional Scale (PSFS) which consists of up to five self-nominated items that the participant perceives to most interfere with their daily functioning. The participant rates each item on a numerical scale 0 to 10 where 0 represents “no difficulties” and 10 represents “can’t do it at all”. This scale will be completed at the beginning and end of each 3-week intervention period. Usage of the preferred rescue medication (paracetamol) will be monitored throughout the 30-week duration of the study. The 2005-Complete Digestive Stool Analysis (CDSA) kit will be used to monitor the probiotic concentration on four occasions (Weeks 2, 5, 7 and 10).

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