Probiotic for Pain Osteoarthritis

NCT03968770 | Unknown

• 1 other identifier: Microbiota-PainOA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Osteoarthritis; Pain; Microbiota

Outcome Measures

Primary Outcomes (4)

• Change from Visual analogue scale (VAS) at 6 weeks

  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 \[in the center of the anterior aspect of patella (knee) and the trochanter site (hip)\]

  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.

  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

  Baseline, immediately post-intervention (6 weeks), and follow up (4 weeks)

Study Arms (2)

Experimental group

EXPERIMENTAL

Probiotic product plus usual medical care (NSAIDs use and the promotion of a healthy lifestyle).

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).

Dietary Supplement: Control group; Other: Usual medical care

Interventions

Experimental group DIETARY_SUPPLEMENT

Probiotic (Lactobacillus casei) once daily taken by 6 weeks.

Experimental group

Control group DIETARY_SUPPLEMENT

Placebo of Probiotic once daily taken by 6 weeks.

Control group

Usual medical care OTHER

NSAIDs, once daily taken and promotion of a healthy lifestyle by 6 weeks.

Control group; Experimental group

Eligibility Criteria

• Age: 50 Years - 90 Years
• 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) 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.

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 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

MeSH Terms

Conditions

Osteoarthritis; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind (Subject, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: May 30, 2019
• Study Start: June 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2021
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share