NCT03985709

Probiotic for Osteoarthritis

Status unknown NA Last updated 14 June 2019

What this trial tests

NA trial testing Probiotic product in Osteoarthritis of Multiple Joints in 40 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
31 December 2021

1 July 2022

Quick facts

Lead sponsor	Fondazione Don Carlo Gnocchi Onlus
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 February 2020
Primary completion	31 December 2021
Estimated completion	1 July 2022
Sites	1 location across Italy

Drugs / interventions tested

• Probiotic product

Conditions studied

• Osteoarthritis of Multiple Joints — all drugs for Osteoarthritis of Multiple Joints →

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

Adults 50 to 90, any sex, with Osteoarthritis of Multiple Joints. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The gut microbiome appears to be a significant contributor to musculoskeletal health and disease. Microbiome composition and its functional implications have been associated with prevention of bone loss and/or reducing fracture risk. Genetic background, gender, dietary intake, and social factors are also important factors which contribute to the musculoskeletal health, as well as to the normal balance of intestinal microbiota. The link between gut microbiota and joint inflammation in murine models of arthritis has been established, and it is now receiving increasing attention in human studies. Recent papers have demonstrated substantial alterations in the gut microbiota in patients with rheumatoid arthritis (RA) and osteoarthritis (OA). These alterations resemble those established in systemic inflammatory conditions (inflammatory bowel disease, spondyloarthritides, psoriasis), which include decreased microbial diversity and lower abundances of bacteria belonging to the Firmicutes phylum that are known to have immunoregulatory properties.These new findings open important future horizons both for understanding disease pathophysiology and for developing novel biomarkers and treatment strategies. Further investigation into the mechanisms linking changes in the microbiome to alterations in bones and joints is necessary. Next Generation Sequencing, metatranscriptomic analysis, and metabolomic approaches may provide yet-greater insight and help further understand these mechanisms. To investigate gut microbiota change will be associated with the sintoms of knee and / or hip OA in italian patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Potential Role of Probiotics in the Management of Osteoarthritis Pain: Current Status and Future Prospects.
   Rahman SO, Bariguian F, Mobasheri A. · · 2023 · cited 30× · PMID 37656392 · DOI 10.1007/s11926-023-01108-7
2. The Complex Interplay between the Gut Microbiome and Osteoarthritis: A Systematic Review on Potential Correlations and Therapeutic Approaches.
   Marchese L, Contartese D, Giavaresi G, Di Sarno L, et al · · 2023 · cited 18× · PMID 38203314 · DOI 10.3390/ijms25010143