An interventional study of Experimental group and Control group in Osteoarthritis of Multiple Joints, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
Many people with symptomatic Osteoarthritis (OA) report chronic joint pain, especially if those patients are older than 50 years. In Europe OA is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. Gut microbiota has been proven to be of crucial importance in maintaining human health. However, the microbiota profile changes with aging, while the loss of microbiota diversity and the alterations in the optimal composition and quantity of beneficial microbes are believed to increase the risk of many diseases. Interestingly, emerging evidence leads to the hypothesis that alterations in the gut microbiome could also be considered as possible triggering factors in the onset of musculoskeletal disorders such as OA. We hypothesize that these patients with pain-OA will demonstrate an alteration of the gut microbiota to associated with the intensity of pain.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Probiotic product plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).
Dietary Supplement: Experimental group · Other: Usual medical care
Sham probiotical plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).
Dietary Supplement: Control group · Other: Usual medical care
Probiotic (Lactobacillus casei) once daily taken by 6 weeks.
Placebo of Probiotic once daily taken by 6 weeks.
NSAIDs, once daily taken and promotion of a healthy lifestyle by 6 weeks.
Change from Visual analogue scale (VAS) at 6 weeks
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Pressure Pain Thresholds (PPT) at 6 weeks
PPT will be assessed bilaterally \[in the center of the anterior aspect of patella (knee) and the trochanter site (hip)\]
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Inflammatory cytokines at 6 weeks
Fasting serum concentrations of interleukin (IL)-6, tumor necrosis factor (TNF)-α, soluble IL-6 receptor (IL-6sR), soluble IL-1 receptor (IL-1sR), and C-reactive protein (CRP) were measured by enzyme-linked immunosorbent assays.
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Microbiota at 6 weeks
Microbiota composition will be identified through fecal samples for total genomic DNA extraction. The bacteria belonging to Clostridium sensu stricto, Enterobacteriaceae, Escherichia coli, Bifidobacterium, Lactobacillus and yeast were dosed using quantitative PCR approach targeted on 16S rRNA gene
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus