Role of Nutritional Support With Probiotics in Adult Outpatients With Symptomatic COVID-19: a Randomized Dietary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Global symptom score
研究概览
简要总结
There is evidence that some types of probiotics play a role in alleviation of symptoms of acute respiratory tract infections and bursting immune response to respiratory and enteric viruses. Available data serves a rationale for the study exploring a role of nutritional support with probiotics in adult outpatients with COVID-19. Hypothesis of the study is that a proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from COVID-19 and enhance specific immune response to SARS-CoV-2 antigens.
详细描述
One hundred adults with confirmed (PCR or antigen test) symptomatic COVID-19 lasting upto 5 days will be screened for the study. When the subject meets enrollment criteria, he/she will be randomized to take an investigational product (probiotic, test dietary supplement, TDS), a mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28 days after enrollment. During observation, the patient will keep Respiratory Illness Diary. Blood serum will be collected at baseline, day 0-5 (Nurse Visit 1), after 28-35 days (Nurse visit 2), and 6 months (Nurse visit 3) for evaluation of anti-SARS-CoV-2 antibodies to nucleocapsid and spike antigents. In 3 months, investigator/family physician will collect Post-COVID-19 Questionnaire
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 non-pregnant female;
- •Informed virtual pre-consent and paper signed consent forms;
- •Confirmed symptomatic COVID-19 lasting 0-5 days;
- •Subject understands and agrees to comply with study procedures including triple blood analysis for anti-SARS-CoV-2 IgG;
排除标准
- •Risk for the complicated course of COVID-19 due to:
- •Hypertension; 1.
- •Diabetes mellitus; 1.
- •Immunosuppressive conditions; 1.
- •Chronic pathology of the respiratory system ; 1.
- •Chronic pathology of the cardiovascular system ; 1.
- •Malignant tumor ; 1.
- •Systemic inflammatory connective tissue disease ; 1.
- •Cerebrovascular disease ; 1.
- •Chronic hepatitis. Hepatic cirrhosis; 1.
- •Inflammatory bowel diseases ; 1.
- •Chronic kidney disease ;
- •Drug or alcohol abuse as suspected by investigator;
- •History of persistent diarrhea of any cause;
- •Use of pre- or probiotics during the last 2 weeks before enrollment;
- •Allergy to any components of the TDS;
- •Technical difficulties to perform virtual study visits.
- •Inability to perform a blood test for antibodies after 6 months
- •Inability to swallow capsules, or choking / coughing while eating
结局指标
主要结局
Global symptom score
时间窗: 10 days
Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease)
次要结局
- Hospitalization rate(28 days)
- 8 - point ordinal severity scale of coronavirus disease-19(28 days)
- Time to recovery(28 days)
- Percent of completely recovered patients(28 days)
研究者
Sergei Gerasymov, MD, PhD
Principal Investigator
Nordic Biotic Sp. z o.o.