Probiotic for Osteoarthritis

Osteoarthritis of Multiple Joints Clinical Trial

Official title:

Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03985709
• Other study ID #: Probiotic in OA
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: June 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: December 31, 2021
• 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). 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Multiple Joints

Intervention

Other:
• Probiotic product
Probiotic (Lactobacillus casei) once daily taken by 3 months.

Locations

Country	Name	City	State
Italy	Jorge Hugo Villafañe	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Pain Intensity at 3 months.	Visual Analogue Scale, 0: no pain, 100: maximum pain	Baseline, immediately post-intervention (3 months).
Primary	Change from range of Pressure Pain Thresholds at 3 months	Algometry, will be assessed bilaterally [in the center of the anterior aspect of patella (knee) and the trochanter site (hip). The range of values of the pressure algometer was 0 to 10 kg.	Baseline, immediately post-intervention (3 months).
Secondary	Change from concentrations of Inflammatory cytokines at 3 months.	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. All samples were measured in duplicate, and the average of the two values was used for data analyses.	Baseline, immediately post-intervention (3 months).
Secondary	Change from Microbiota at 3 months.	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 (3 months).