NCT03968770

Probiotic for Pain Osteoarthritis

A Probiotic Intervention on Pain Hypersensitivity and Microbiota Composition in Patients With Pain-osteoarthritis: Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Osteoarthritis of Multiple Joints

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental group	Probiotic (Lactobacillus casei) once daily taken by 6 weeks.
DIETARY_SUPPLEMENT	Control group	Placebo of Probiotic once daily taken by 6 weeks.
OTHER	Usual medical care	NSAIDs, once daily taken and promotion of a healthy lifestyle by 6 weeks.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-01-01
• Completion: 2021-07-01
• First posted: 2019-05-30
• Last updated: 2019-05-30