Probiotic for Pain Osteoarthritis

Osteoarthritis of Multiple Joints Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03968770
• Other study ID #: Microbiota-PainOA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 2021

Study information

• Verified date: May 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Jorge H Villafañe, PhD
• Phone: +39 3395857563
• Email: mail[@]villafane.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Multiple Joints

Intervention

Dietary Supplement:
• Experimental group
Probiotic (Lactobacillus casei) once daily taken by 6 weeks.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Visual analogue scale (VAS) at 6 weeks		Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Primary	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)]	Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Primary	Change from Inflammatory cytokines at 6 weeks	Fasting serum concentrations of interleukin (IL)-6, tumor necrosis factor (TNF)-a, soluble IL-6 receptor (IL-6sR), soluble IL-1 receptor (IL-1sR), and C-reactive protein (CRP) were measured by enzyme-linked immunosorbent assays.	Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Primary	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	Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)