Osteoarthritis of Multiple JointsNCT03968770
Probiotic for Pain Osteoarthritis
A study testing Experimental group and Usual medical care in people with Osteoarthritis of Multiple Joints, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Many people with symptomatic Osteoarthritis (OA) report chronic joint pain, especially if those patients are older than 50 years. In Europe OA is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. 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?
- Experimental group and Usual medical care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to Jul 2021
- 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) and who require and eligible for chronic, daily therapy with an NSAIDs to control OA sign and symptoms. 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 with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
- 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
No sites are listed yet.
About this study
Official title: A Probiotic Intervention on Pain Hypersensitivity and Microbiota Composition in Patients With Pain-osteoarthritis: Study Protocol for a Randomized Controlled Trial
Many people with symptomatic Osteoarthritis (OA) report chronic joint pain, especially if those patients are older than 50 years. In Europe OA is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. Gut microbiota has been proven to be of crucial importance in maintaining human health. However, the microbiota profile changes with aging, while the loss of microbiota diversity and the alterations in the optimal composition and quantity of beneficial microbes are believed to increase the risk of many diseases. Interestingly, emerging evidence leads to the hypothesis that alterations in the gut microbiome could also be considered as possible triggering factors in the onset of musculoskeletal disorders such as OA. We hypothesize that these patients with pain-OA will demonstrate an alteration of the gut microbiota to associated with the intensity of pain.
- Conditions
- Osteoarthritis of Multiple Joints
- Being tested
- Experimental group, Control group, Usual medical care
- Keywords
- Osteoarthritis, Pain, Microbiota
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDietary supplement
Probiotic (Lactobacillus casei) once daily taken by 6 weeks.
Control groupDietary supplement
Placebo of Probiotic once daily taken by 6 weeks.
Usual medical careOther
NSAIDs, once daily taken and promotion of a healthy lifestyle by 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Probiotic product plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle). Receives: Dietary Supplement: Experimental group; Other: Usual medical care |
| Control group | Placebo comparator | Sham probiotical plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle). Receives: Dietary Supplement: Control group; Other: Usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Visual analogue scale (VAS) at 6 weeks
Measured: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Pressure Pain Thresholds (PPT) at 6 weeks
PPT will be assessed bilaterally [in the center of the anterior aspect of patella (knee) and the trochanter site (hip)]
Measured: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Inflammatory cytokines at 6 weeks
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.
Measured: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Microbiota at 6 weeks
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 (6 weeks), and follow up (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJul 2021 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- NCT03968770
- Sponsor's protocol ID
- Microbiota-PainOA
- Status last verified
- May 2019
- First submitted
- 25 May 2019
- Last updated
- 30 May 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 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Probiotic Intervention on Pain Hypersensitivity and Microbiota Composition in Patients With Pain-osteoarthritis: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03968770
- Acronym / sponsor ID
- Microbiota-PainOA
- Conditions
- Osteoarthritis of Multiple Joints
- Keywords
- Osteoarthritis, Pain, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 30 May 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.
Many people with symptomatic Osteoarthritis (OA) report chronic joint pain, especially if those patients are older than 50 years. In Europe OA is the most common form of chronic pain condition (34%) reported and entails a high economic and social burden for society. Probiotic treatment has been shown to promote bone metabolism, reduce pain and inflammatory responses of age-related musculoskeletal disorders, including OA. Gut microbiota has been proven to be of crucial importance in maintaining human health. However, the microbiota profile changes with aging, while the loss of microbiota diversity and the alterations in the optimal composition and quantity of beneficial microbes are believed to increase the risk of many diseases. Interestingly, emerging evidence leads to the hypothesis that alterations in the gut microbiome could also be considered as possible triggering factors in the onset of musculoskeletal disorders such as OA. We hypothesize that these patients with pain-OA will demonstrate an alteration of the gut microbiota to associated with the intensity of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Experimental group, Other: Usual medical careProbiotic product plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle). |
| Control group | Placebo comparator | Dietary Supplement: Control group, Other: Usual medical careSham probiotical plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle). |
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) and who require and eligible for chronic, daily therapy with an NSAIDs to control OA sign and symptoms. A physiatrist (physician) will establish the diagnosis of pain-OA.
Key exclusion criteria (6 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 with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
- 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.
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 |
|---|---|---|
| Experimental groupProbiotic (Lactobacillus casei) once daily taken by 6 weeks. | Dietary supplement | Experimental group |
| Control groupPlacebo of Probiotic once daily taken by 6 weeks. | Dietary supplement | Control group |
| Usual medical careNSAIDs, once daily taken and promotion of a healthy lifestyle by 6 weeks. | Other | Control group, Experimental group |
Primary outcome
Change from Visual analogue scale (VAS) at 6 weeks
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
Change from Pressure Pain Thresholds (PPT) at 6 weeks
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
PPT will be assessed bilaterally [in the center of the anterior aspect of patella (knee) and the trochanter site (hip)]
Change from Inflammatory cytokines at 6 weeks
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
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.
Change from Microbiota at 6 weeks
Time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 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
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group and Usual medical care in people with Osteoarthritis of Multiple Joints, run by Fondazione Don Carlo Gnocchi ETS.
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 6 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Visual analogue scale (VAS) at 6 weeks (time frame: Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)). The study lists 4 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 30 May 2019.