The Effects of Probiotic Lactobacillus Acidophilus and Colchicine on the Control of Symptoms, Duration, and Disease Progression of Mild and Moderate Cases of COVID-19: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- symptoms improvement
研究概览
简要总结
Probiotics and or Colchicine may be considered as an option of treatment since they have anti-viral effect anti-inflammatory and immunomodulatory effect. A total of 150 participants were were randomly assigned (1:1:1) to receive either the standard treatment protocol and colchicine or the standard treatment protocol and probiotics or the standard treatment protocol alone for two weeks. Participants followed up twice weekly by telephone.
详细描述
Rational:
At the end of 2019, a novel coronavirus was identified as the causative of a cluster of pneumonia cases in Wuhan, China. resulting in an epidemic throughout China, followed by a global pandemic. In February 2020, the World Health Organization announced the disease COVID-19, which stands for coronavirus disease 2019.
Gut microbiota configuration was associated with COVID-19 disease severity, and altered gut microbiota persisted even after clearance of the virus, suggesting that the virus might inflict prolonged harm to human microbiome homoeostasis.
Probiotics as an intestinal microbe regulator, not only improve the ability of the GI microbiota to modulate immune activity, but also strengthen the body's immune system, inhibit allergic reactions and has a significant role especially in the anti-viral immunomodulation.
Colchicine is an anti-inflammatory medication commonly used for the treatment systemic auto inflammatory diseases such as familial Mediterranean fever and Behçet's disease. Its mechanism of action is through inhibition of neutrophil chemotaxis and activity in response to vascular injury .
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 (Participant)
盲法说明
The researcher will use sealed envelopes containing code for intervention or control.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged (18-60) years with confirmed criteria of COVID-19 infection. Mild cases: Participants have mild symptoms such as anosmia, loss of taste, fever or respiratory tract symptoms, gastrointestinal symptoms, etc. and free chest imaging. Moderate Cases: Participants have symptoms such as fever, respiratory tract symptoms, gastrointestinal symptoms, etc. and pneumonia manifestations can be seen in chest imaging
排除标准
- •Age below 18 years or above 60 years.
- •Pregnancy, lactation.
- •Any co-morbidities e.g. (DM, hypertension, Asthma)
- •Participants receiving immunosuppressive or chemotherapy drugs.
- •Active malignancy
- •Severe confirmed cases, fulfilling any of the following criteria:
- •Respiratory rate more than 30/min.
- •Blood oxygen saturation of less than 93%.
- •Lung infiltrates >50% of the lung fields or rapid progression within 24-48 hours.
- •Participants need respiratory support e.g. high flow oxygen, non-invasive or invasive mechanical ventilation.
- •Critical cases defined as: occurrence of respiratory failure requiring mechanical ventilation; Presence of shock; other organ failure that requires monitoring and treatment in the ICU
研究组 & 干预措施
Group A (Colchicine group)
consisted of COVID-19 participants with mild to moderate disease who received the recommended course of care in accordance with the protocol established by the Egyptian Supreme Council of University Hospitals, as well as Colchicine tablets (0.5 mg) three times per day for three days and subsequently twice per day for four days
干预措施: Colchicine 0.5 MG (Drug)
Group B (Probiotic group)
consisted of COVID-19 participants with mild and moderate COVID-19 severity got probiotics in the form of oral sachets once daily for two weeks in addition to protocol prescribed by the Egyptian Supreme Council of University Hospitals.
干预措施: Probiotic Formula (Dietary Supplement)
Group C (Control group)
consisted of COVID-19 participants with mild and moderate severity who received the recommended course of care in accordance with the protocol established by the Egyptian Supreme Council of University Hospitals (Vitamin C 500 mg twice daily, Vitamin D3 2000-4000 IU/day, Zinc 75 mg once daily for two weeks, and necessary protocol of management based on case assessment and severity).
干预措施: Standard protocol (Other)
结局指标
主要结局
symptoms improvement
时间窗: two weeks
Discharge from isolation after 10 days after symptom onset, plus at least 3 additional days without symptoms (including without fever and without respiratory symptoms) According to WHO recommendations published on 27 May 2020.
次要结局
- Development of new symptoms.(two weeks)
- Need for oxygen supplementation.(two weeks)
研究者
samar osama ahmed hassan
Dr.
Ain Shams University