Probiotic for Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03985709|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of Multiple Joints||Other: Probiotic product||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deciphering the Role of the Microbiota in Osteoarthritis for Improving Therapy|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Probiotcal group
Probiotic (Lactobacillus casei) once daily taken by 3 months
Other: Probiotic product
Probiotic (Lactobacillus casei) once daily taken by 3 months.
- 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.
- Change from concentrations of Inflammatory cytokines at 3 months. [ Time Frame: Baseline, immediately post-intervention (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.
- Change from Microbiota at 3 months. [ Time Frame: Baseline, immediately post-intervention (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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985709
|Contact: Jorge H Villafañe, PhD||+39 email@example.com|
|Jorge Hugo Villafañe|
|Milan, Italy, 10045|
|Principal Investigator:||Jorge H Villafañe, PhD||Fondazione Don Carlo Gnocchi Onlus|