Official Title
Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy
Brief Title
Probiotic for Osteoarthritis
Protocol ID
NCT03985709
Lead Sponsor
Fondazione Don Carlo Gnocchi Onlus
Brief Summary
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.
Study Period
-
Enrollment Count
40 participants
Eligibility Criteria
Inclusion Criteria:
- All subjects will have hip or knee OA according on radiographic findings
(Kellgren-Lawrence scale ≥3). A physiatrist (physician) will establish the diagnosis
of pain-OA.
Exclusion Criteria:
- Psychiatric or neurological disorders, celiac disease, lactose intolerance, or
allergies or other ongoing illnesses (i.e., irritable bowel syndrome, diabetes,
ulcerative colitis, etc.) or recent antibiotic treatment (i.e., <3 months before the
beginning of the study).
- Participants require treatment with aspirin > 325 mg /day.
- Participants who smoked more than 10 cigarettes per day were excluded.
- Participants will be excluded also if they score greater than 6 points on the Beck
Depression Inventory (BDI) or more than 30 points in the State Trait Anxiety
Inventory (STAI), dementia and not Italian speaking due to the high level of
language skills required for questionnaires and quantitative sensory testing.
- Post-traumatic OA (e.g., fractures), congenital hip deformities, surgical
interventions to the hip or knee, Legg-Calvé-Perthes disease, or degenerative or
non-degenerative neurological conditions in which pain perception is altered will be
excluded
Filters
Osteoarthritis of Multiple Joints
NA
UNKNOWN
ADULT
OLDER_ADULT