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Effect of Probiotic Supplements on Osteoarthritis Outcomes

Study acronym: ProOA23
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study description shortened, about 13 words
    • Site details revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2024 to Jul 1, 2024
    • Interventions: Probiotic supplements/placebo supplement (Dietary Supplement) to Placebo supplements (Dietary Supplement), Probiotic supplements (Dietary Supplement)
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Dysbiosis of the gut microbiota is believed to contribute to the development and progression of osteoarthritis (OA), suggesting a role for probiotics in the treatment of OA. Animal studies have shown that certain probiotic strains decrease the inflammatory responses, pain sensitization and OA progression. There are, however, few clinical studies in humans to support this. In this double-blinded randomized controlled trial we will investigate the effect of 6-months probiotic supplements compared to placebo on OA related outcomes in females with diagnosed knee OA.
Trial Details
NCT Number NCT06459700
Lead Sponsor Lund University
Collaborators: Probi AB
Conditions
(from sponsor)		 Knee Osteoarthritis
Related terms Osteoarthritis, Knee
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov