Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062745) titled 'Effects of capsules containing lactic acid bacteria on knee joint symptoms' on Sept. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Megmilk Snow Brand Co., Ltd

Condition: Condition - Healthy volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the effects of a test food on knee joint symptoms Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of a test food for 12 weeks (one capsule, once a day) Interventions/Control_2 - Intake of a placebo for 12 weeks (one capsule, once a day)

Eligibility: Age-lower limit - 30 years-old

Gender - Male and Female Key inclusion criteria - 1) Males and females aged 20 years or more and less than 65 years with knee joint pain 2) Persons with KL grade 0 or 1 diagnosed by knee X-ray 3) Persons who have received sufficient briefing of the objective and content of the study, fully understand and agree to voluntarily participate, and are able to sign a written informed consent form Key exclusion criteria - 1) Persons with a medical history of rheumatism 2) Persons with leg pain or numbness 3) Persons diagnosed with meniscal lesions of the knee or other knee joint diseases 4) Individuals with current or previous diseases causing pain or arthritis, or diseases affecting cartilage or bone metabolism 5) Persons receiving medical treatment for serious cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disorders or with a medical history of these disorders 6) Persons with a history of visiting an orthopedic surgeon frequently or having a plan to visit an orthopedic surgeon during the study 7) Persons with a history of visiting an osteopathic clinic frequently or planning to visit one during the study 8) Individuals taking supplements or health foods with claims related to knee joint function or symptoms, including Foods for Specified Health Uses and Foods with Function Claims 9) Individuals using medicines or quasi-drugs intended to alleviate knee joint symptoms 10) Individuals consuming foods containing high levels of lactic acid bacteria or bifidobacteria three or more days per week 11) Persons consuming large amounts of foods high in lactic acid bacteria or bifidobacterium 12) Persons taking lactic acid bacteria- or bifidobacterium-enriched health foods 13) Persons taking medicines containing lactic acid bacteria or bifidobacterium as active ingredients 14) Individuals with a potential allergy to the test food, particularly those with allergies to milk or dairy products 15) Persons who are pregnant or lactating, or intending to become pregnant during the study period 16) Persons having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study 17) Persons who have taken part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in another clinical study 18) Persons deemed unsuitable by the investigator Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 15 Day Date of IRB - 2026 Year 08 Month 15 Day Anticipated trial start date - 2027 Year 01 Month 09 Day Last follow-up date - 2027 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071764

Disclaimer: Curated by HT Syndication.