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Probiotic for Pain Osteoarthritis

Primary Purpose

Osteoarthritis of Multiple Joints

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Experimental group

Control group

Usual medical care

About this trial

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

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) 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.

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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Visual analogue scale (VAS) at 6 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)]

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03968770

First Posted

May 25, 2019

Last Updated

May 29, 2019

Sponsor

Fondazione Don Carlo Gnocchi Onlus

1. Study Identification

Unique Protocol Identification Number

NCT03968770

Brief Title

Probiotic for Pain Osteoarthritis

Official Title

A Probiotic Intervention on Pain Hypersensitivity and Microbiota Composition in Patients With Pain-osteoarthritis: Study Protocol for a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2019 (Anticipated)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

July 2021 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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, Pain, Microbiota

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double Blind (Subject, Outcomes Assessor)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Experimental group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Control group

Intervention Description

Placebo of Probiotic once daily taken by 6 weeks.

Intervention Type

Other

Intervention Name(s)

Usual medical care

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Visual analogue scale (VAS) at 6 weeks

Time Frame

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

Title

Change from Pressure Pain Thresholds (PPT) at 6 weeks

Description

PPT will be assessed bilaterally [in the center of the anterior aspect of patella (knee) and the trochanter site (hip)]

Time Frame

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

Title

Change from Inflammatory cytokines at 6 weeks

Description

Time Frame

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

Title

Change from Microbiota at 6 weeks

Description

Time Frame

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

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jorge H Villafañe, PhD

Phone

+39 3395857563

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Probiotic for Pain Osteoarthritis

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