Evaluation of the Clinical Outcome of Probiotics in Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
研究概览
简要总结
Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.
详细描述
- Patients will be recruited and evaluated for eligibility.
- Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.
- Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks.
- Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.
- Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study.
- Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.
- Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, male or female.
- •Patients are willing to sign a written informed consent.
- •Patients fulfilling American college of rheumatology classification criteria for SLE.
- •Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.
排除标准
- •Patients ˂ 18 years or ˃65 years of age.
- •Patients with a history of drug allergies to probiotics administration.
- •Pregnant or breastfeeding females.
- •Current probiotics use.
- •Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
- •patients suffering from active severe neuropsychiatric manifestations of SLE.
- •Patients with other auto-immune diseases.
- •Patients suffering from any type of cancer.
- •patients participating in other clinical trials.
研究组 & 干预措施
Interventional group
20 patients will receive the standard therapy in addition to two capsules once daily of probiotic Lacteol Forte® Capsules for 12 weeks
干预措施: Lacteol forte capsules (Drug)
结局指标
主要结局
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
时间窗: At baseline and at 12 weeks
Change in disease activity measured by SLEDAI-2K score. The most appropriate SLEDAI-2K cut-off score for definition of active disease which links to the need to increase therapy is 3 or 4
次要结局
- Improvement of serum complement(At baseline and at 12 weeks)
- Pain assessment(At baseline and at 12 weeks)
- Improvement of immunologic parameters(At baseline and at 12 weeks)
- patients' quality of life(At baseline and at 12 weeks)
- Incidence of potential adverse effects(Weekly up to 12 weeks)
研究者
Rana Sayed Fouad
Principal investigator
Ain Shams University