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Probiotic for Pain Osteoarthritis

NCT03968770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-05-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Experimental group

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

DIETARY_SUPPLEMENT

Control group

Placebo of Probiotic once daily taken by 6 weeks.

OTHER

Usual medical care

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

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Jorge H Villafañe, PhD · Fondazione Don Carlo Gnocchi Onlus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2020-01-31
Completion
2021-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968770 on ClinicalTrials.gov