Official Title
A Probiotic Intervention on Pain Hypersensitivity and Microbiota Composition in Patients With Pain-osteoarthritis: Study Protocol for a Randomized Controlled Trial
Brief Title
Probiotic for Pain Osteoarthritis
Protocol ID
NCT03968770
Lead Sponsor
Fondazione Don Carlo Gnocchi Onlus
Brief 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.
Study Period
Enrollment Count
50 participants
Eligibility Criteria
Inclusion Criteria:
- All subjects will have hip or knee OA according on radiographic findings
(Kellgren-Lawrence scale ≥3) and who require and eligible for chronic, daily therapy
with an NSAIDs to control OA sign and symptoms. 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 with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin
or esomeprazole, etc.
- 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