Osteoarthritis of Multiple JointsNCT03985709
Probiotic for Osteoarthritis
A study testing Probiotic product in people with Osteoarthritis of Multiple Joints, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Multiple Joints
- What is being tested?
- Probiotic product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy
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
- Being tested
- Probiotic product
- Keywords
- Osteoarthritis, Microbiota, Probiotic
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic productOther
Probiotic (Lactobacillus casei) once daily taken by 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotcal group | Experimental | Probiotic (Lactobacillus casei) once daily taken by 3 months Receives: Other: Probiotic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Pain Intensity at 3 months.
Visual Analogue Scale, 0: no pain, 100: maximum pain
Measured: 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.
Measured: Baseline, immediately post-intervention (3 months).
Secondary outcomes (2)
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.
Measured: Baseline, immediately post-intervention (3 months).
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.
Measured: Baseline, immediately post-intervention (3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Feb 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Multiple JointsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Jorge H Villafañe, PhD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985709
- Sponsor's protocol ID
- Probiotic in OA
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy
- ClinicalTrials.gov ID
- NCT03985709
- Acronym / sponsor ID
- Probiotic in OA
- Conditions
- Osteoarthritis of Multiple Joints
- Keywords
- Osteoarthritis, Microbiota, Probiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotcal group | Experimental | Other: Probiotic productProbiotic (Lactobacillus casei) once daily taken by 3 months |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic productProbiotic (Lactobacillus casei) once daily taken by 3 months. | Other | Probiotcal group |
Primary outcome
Change from Pain Intensity at 3 months.
Time frame: Baseline, immediately post-intervention (3 months).
Visual Analogue Scale, 0: no pain, 100: maximum pain
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.
2 secondary outcomes
Change from concentrations of Inflammatory cytokines at 3 months.
Time frame: Baseline, immediately post-intervention (3 months).
Change from Microbiota at 3 months.
Time frame: Baseline, immediately post-intervention (3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge H Villafañe, PhD principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic product in people with Osteoarthritis of Multiple Joints, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge H Villafañe, PhD (+39 3395857563, mail@villafane.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Pain Intensity at 3 months. (time frame: Baseline, immediately post-intervention (3 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.