Evaluating the Efficacy of Probiotic Supplements on Osteoarthritis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcome assessors were blinded to participant data. the researcher coded patient data before analysis
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Control group
OA patients will receive only standard of care
干预措施: Control (Drug)
probiotic group
OA patients will receive probiotic supplements (2 times daily) added to the standard of care.
干预措施: Probiotic Formula (Drug)
结局指标
主要结局
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 3 months
A self-administered measure used in assessing pain, stiffness, and function in OA patients
Visual Analogue Scale (VAS)
时间窗: 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.
次要结局
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(3 months)
研究者
Asmaa Abdelfattah Elsayed
Lecturer of clinical pharmacy
Beni-Suef University