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Completed

NCT Number: NCT07364578

Probiotic Supplements in Osteoarthritis

The current study aims to evaluate the effectiveness of adding probiotics to the standard of care in improving OA patient-related outcomes such as pain, stiffness, and physical activity.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asmaa Abdelfattah Elsayed

Banī Suwayf, 82511, Egypt

About this study

Osteoarthritis (OA) is a severe progressive chronic arthropathy causing articular remodeling and inflammation of synovial tissue. The disease involves the entire synovial joint, including the cartilage, joint lining, and subchondral bone. OA causes pain, swelling, and stiffness, consequently hindering the patient's ability to perform their main daily activities, which often leads to social isolation and depression. Up till now, there is no cure for OA treatment options target either symptomatic relief (mainly pain) such as acetaminophen, glucosamine, chondroitin sulfate, and non-steroidal anti-inflammatory drugs (NSAIDs) or structure repair.

Probiotics are live and active microorganisms widely known as the gut's beneficial bacteria. They are taken to alter the GI flora and provide health benefits such as achieving optimal digestion and immunological function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Probiotic Formula

Drug

probiotic supplements (lactobacillus, 2 times daily) added to standard of care

Control

Drug

standard of care

Primary outcomes

  1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 3 months

    A self-administered measure used in assessing pain, stiffness, and function in OA patients

  2. Visual Analogue Scale (VAS)

    Time frame: 3 months

    A pain rating scale that represents the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks the line according to his/her perception of their current state.

Secondary outcomes

  1. The Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 3 months

    a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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