Probiotic supplements for knee osteoarthritis

Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients

This trial will try whether adding a daily probiotic to usual care helps adults with knee osteoarthritis feel less pain and stiffness and be more active.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beni-Suef University (Academic / other)
• Locations: 1 site (Banī Suwayf)
• Trial ID: NCT07364578 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial enrolls adults with symptomatic knee osteoarthritis who meet ACR clinical criteria and assigns them to receive a probiotic formula or a control in addition to standard care. Key exclusions include inflammatory arthritides, recent antibiotic use, prior knee replacement on the affected knee, pregnancy, significant organ failure, and certain GI disorders. The study tracks patient-reported outcomes such as pain, stiffness, and physical activity over scheduled follow-up visits to compare changes between groups. Safety and tolerability of the probiotic supplement are also monitored.

Who should consider this trial

Good fit: Adults over 18 with symptomatic knee osteoarthritis who meet the ACR clinical criteria for knee OA and can attend visits at the study site are the intended participants.

Not a fit: Patients with inflammatory arthritis (e.g., rheumatoid arthritis), prior or planned knee replacement, recent antibiotic use, major organ failure, active GI disease, pregnancy or breastfeeding, heavy smokers, or on immunosuppressive therapy are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, adding probiotics to usual care could reduce pain and stiffness and help people with knee osteoarthritis do more daily activities.

How similar studies have performed: Small studies and preclinical work have shown mixed signals that certain probiotics may reduce inflammation or symptoms in OA, but large Phase 3 evidence is still limited.

Eligibility criteria

Inclusion Criteria:

Patients (both sexes) aged above 18 years who met the American College of Rheumatology (ACR) clinical criteria for KOA \[7\] and had symptomatic OA of at least one knee (index knee).

Exclusion Criteria:

1. Rheumatoid arthritis or other active generalized inflammatory comorbidities affecting the gastrointestinal tract (IBD, celiac disease)
2. Performed a total knee replacement on the affected knee or the waiting list for joint replacement
3. surgeries (such as gastric bypass) or Other concomitant injuries can override OA symptoms or interfere with physical activity.
4. Malabsorption disorders, systemic organ failure (liver, renal, cardiac)
5. Use corticosteroids with doses above 10 mg/day or Intra-articular injections during the previous 6 months.
6. Recent antibiotic treatment (i.e., \<2 months before the beginning of the study).
7. Pregnancy/breastfeeding
8. Participants who smoked more than 10 cigarettes per day were excluded.
9. Immunosuppressive treatment or impaired immune system
10. Chronic or acute diarrhea
11. Blood/plasma donation/transfusion during the 3 months of the study
12. Non-controlled diabetes
13. Allergy with regards to any of the study product ingredients.
14. Post-traumatic OA (e.g., fractures), congenital hip deformities, or degenerative or non-degenerative neurological conditions can alter pain perception.

Where this trial is running

Banī Suwayf

• Asmaa Abdelfattah Elsayed — Banī Suwayf, Egypt (Recruiting)

Study contacts

• Principal investigator: Asmaa Elsayed — Beni-Suef University
• Study coordinator: Asmaa A Elsayed

Conditions Osteoarthritis, Knee