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Effects of Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules on the knee joint function, gut microbiota and systemic inflammation in patients with kneeosteoarthritis:

Effects of Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules on the knee joint function, gut microbiota and systemic inflammation in patients with kneeosteoarthritis: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098256
Enrollment
Unknown
Registered
2025-03-05
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis

Interventions

Probiotic group:Lifestyle suggestion+glucosamine sulfate+probiotics (2 capsules, tid, 4 weeks)
Placebo group:Lifestyle suggestion+glucosamine sulfate+placebo (2 capsules, tid, 4 weeks)

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with unilateral or bilateral Osteoarthritis, KL grade 2-3 on knee weight-bearing radiographs; 2. Visual analogue scalescore greater than or equal to 3; 3. Age between 30-70; 4. Willing to comply with the research procedures and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous history of knee trauma and surgery, with extra-articular deformity; 2. Use of probiotics or antibiotics in the past 3 months; 3. Combined with rheumatoid, rheumatic, autoimmune, infectious, cardiovascular or respiratory chronic diseases; 4. Pregnant and lactating women; 5. Abnormal defecation or history of digestive tract diseases; 6. Patients known to be allergic to glucosamine sulfate.

Design outcomes

Primary

MeasureTime frame
Pain improvement rate (proportion of patients with VAS score 2cm lower than baseline after 4 weeks of treatment);

Secondary

MeasureTime frame
Knee joint functional indicators (WOMAC score, KOOS score);Systemic inflammation markers (LPS,LBP,TNF-a,IL-6,ESR);Gut microbiota testing;Adverse event rate;

Countries

China

Contacts

Public ContactMing Cheng

The first affiliated hostipal of nanchang university

ndyfy02314@ncu.edu.cn+86 13870839927

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026