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Probiotic for Osteoarthritis

Primary Purpose

Osteoarthritis of Multiple Joints

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Probiotic product
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Multiple Joints focused on measuring Osteoarthritis, Microbiota, Probiotic

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jorge Hugo Villafañe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotcal group

Arm Description

Probiotic (Lactobacillus casei) once daily taken by 3 months

Outcomes

Primary Outcome Measures

Change from Pain Intensity at 3 months.
Visual Analogue Scale, 0: no pain, 100: maximum pain
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.

Secondary Outcome Measures

Change from concentrations of Inflammatory cytokines at 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.
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.

Full Information

First Posted
June 10, 2019
Last Updated
June 13, 2019
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT03985709
Brief Title
Probiotic for Osteoarthritis
Official Title
Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Multiple Joints
Keywords
Osteoarthritis, Microbiota, Probiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotcal group
Arm Type
Experimental
Arm Description
Probiotic (Lactobacillus casei) once daily taken by 3 months
Intervention Type
Other
Intervention Name(s)
Probiotic product
Intervention Description
Probiotic (Lactobacillus casei) once daily taken by 3 months.
Primary Outcome Measure Information:
Title
Change from Pain Intensity at 3 months.
Description
Visual Analogue Scale, 0: no pain, 100: maximum pain
Time Frame
Baseline, immediately post-intervention (3 months).
Title
Change from range of Pressure Pain Thresholds at 3 months
Description
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.
Time Frame
Baseline, immediately post-intervention (3 months).
Secondary Outcome Measure Information:
Title
Change from concentrations of Inflammatory cytokines at 3 months.
Description
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.
Time Frame
Baseline, immediately post-intervention (3 months).
Title
Change from Microbiota at 3 months.
Description
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.
Time Frame
Baseline, immediately post-intervention (3 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge H Villafañe, PhD
Phone
+39 3395857563
Email
mail@villafane.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge H Villafañe, PhD
Organizational Affiliation
Fondazione Don Carlo Gnocchi Onlus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jorge Hugo Villafañe
City
Milan
ZIP/Postal Code
10045
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotic for Osteoarthritis

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