Probiotic for Osteoarthritis

NCT03985709 | Unknown

• 1 other identifier: Probiotic in OA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Multiple Joints

Keywords

Osteoarthritis; Microbiota; Probiotic

Outcome Measures

Primary Outcomes (2)

• Change from Pain Intensity at 3 months.

  Visual Analogue Scale, 0: no pain, 100: maximum pain

  Baseline, immediately post-intervention (3 months).

• 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 Outcomes (2)

• Change from concentrations of Inflammatory cytokines at 3 months.

  Baseline, immediately post-intervention (3 months).

• Change from Microbiota at 3 months.

  Baseline, immediately post-intervention (3 months).

Study Arms (1)

Probiotcal group

EXPERIMENTAL

Probiotic (Lactobacillus casei) once daily taken by 3 months

Other: Probiotic product

Interventions

Probiotic product OTHER

Probiotic (Lactobacillus casei) once daily taken by 3 months.

Probiotcal group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Jorge Hugo Villafañe

Milan, 10045, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jorge H Villafañe, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge H Villafañe, PhD

CONTACT

+39 3395857563; mail@villafane.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 14, 2019
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)