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Probiotic for Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03985709
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Information provided by (Responsible Party):
Jorge Hugo Villafañe, PhD, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Multiple Joints Other: Probiotic product Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Probiotcal group
Probiotic (Lactobacillus casei) once daily taken by 3 months
Other: Probiotic product
Probiotic (Lactobacillus casei) once daily taken by 3 months.

Primary Outcome Measures :
  1. Change from Pain Intensity at 3 months. [ Time Frame: Baseline, immediately post-intervention (3 months). ]
    Visual Analogue Scale, 0: no pain, 100: maximum pain

  2. Change from range of Pressure Pain Thresholds at 3 months [ Time Frame: Baseline, immediately post-intervention (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.

Secondary Outcome Measures :
  1. Change from concentrations of Inflammatory cytokines at 3 months. [ Time Frame: Baseline, immediately post-intervention (3 months). ]
    Fasting serum concentrations of interleukin (IL)-6, tumor necrosis factor (TNF)-α, 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.

  2. Change from Microbiota at 3 months. [ Time Frame: Baseline, immediately post-intervention (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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03985709

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Contact: Jorge H Villafañe, PhD +39 3395857563

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Jorge Hugo Villafañe
Milan, Italy, 10045
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
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Principal Investigator: Jorge H Villafañe, PhD Fondazione Don Carlo Gnocchi Onlus

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Responsible Party: Jorge Hugo Villafañe, PhD, Researcher, Fondazione Don Carlo Gnocchi Onlus Identifier: NCT03985709    
Other Study ID Numbers: Probiotic in OA
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi Onlus:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases