The Role of VSL#3® in the Treatment of Fatigue and Other Symptoms in Long Covid-19 Syndrome: a Randomized, Double-blind, Placebo-controlled Study (DELong#3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Assessment of Fatigue variation after 4 weeks of treatment (t4)
研究概览
简要总结
This study aims to evaluate the effectiveness of VSL#3® in reducing Fatigue and other symptoms in Long Covid Syndrome compared to placebo.
详细描述
Long Covid syndrome is a chronic condition characterized by persistent symptoms experienced by individuals who have recovered from acute coronavirus disease (COVID-19). Among the various symptoms reported, fatigue stands out as a particularly burdensome and pervasive issue, significantly impacting the quality of life and daily functioning of Long Covid patients. Recent studies report that gut microbiota is altered during acute illness and not restored even after several months from recovery. Based on this evidence, modulation of intestinal microbiota can be considered as a possible therapeutic approach for Long Covid Syndrome. On this basis, the aim of this study is to evaluate efficacy of VSL#3® compared to placebo in reducing Fatigue in Long Covid Symptoms.
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
- Double (Participant, Investigator)
盲法说明
Double blinding is achieved by packaging probiotics and placebo in the same sealed and consecutively numbered containers with sachets similar in packaging, smell, and taste. All study participants and on-site study personnel will remain masked for the treatment allocation (randomized controlled trial phase) until database lock and signature of the statistical analysis plan.
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 yo
- •Previous diagnosis of SARS-CoV-2 infection, documented by nasopharyngeal or antigenic molecular swab;
- •Not currently be in quarantine or isolation;
- •No antibiotics treatment in the 30 days prior to the trial;
- •Chalder Fatigue Scale (in dichotomous form)>=4 possibly associated with signs and symptoms of Long COVID-19 syndrome: signs and symptoms that develop during or after SARS-CoV-2 infection, which persist for more than 4 weeks and are not reasonably explained otherwise; signs and symptoms include: fatigue, sleep disturbances, cognitive deficits (i.e. brain fogging, loss of concentration and memory, anxiety, depression), strength deficits, arthralgias and myalgias, gastroenterological alterations (reduced appetite, nausea, changes in bowel habits, abdominal pain
排除标准
- •Cardiovascular and pulmonary disease with moderately severe organ dysfunction (NYHA>2, Borg scale>=2);
- •Decompensated endocrine and metabolic diseases (child cirrhosis >= B, decompensated hypo/hyperthyroidism, decompensated hypoadrenalism)
- •Diagnosis of FM, CFS/ME, and/or IBS prior to SARS-CoV-2 infection;
- •Confirmed diagnoses of neurological pathologies, psychiatric diseases and cognitive disorders prior to SARS-CoV-2 infection;
- •Previous confirmed diagnosis of chronic musculoskeletal pathologies prior to prior to SARS-CoV-2 infection;
- •Refusal to participate in the study / refusal to process personal data;
- •Pregnancy or breastfeeding;
- •Addiction to alcohol or drugs in previous years;
- •Use of other probiotics during the trial;
- •Use of antibiotics during the trial and in the previous 30 days;
- •Substantial change of diet during the trial;
- •Participation in another clinical study in the previous 30 days or previous participation in this same trial;
- •Known intolerance/hypersensitivity to the investigational drug or to the excipients of the placebo formulation
结局指标
主要结局
Assessment of Fatigue variation after 4 weeks of treatment (t4)
时间窗: 4 weeks
To determine if there is a statistically significant variation in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of treatment (t4)
次要结局
- Assessment of Gastrointestinal Symptoms variation after4 weeks of follow-up (t8)(8 weeks)
- Assessment of Fatigue variation after 4 weeks of follow-up (t8)(8 weeks)
- Analysis of Somatization variation after 4 weeks of treatment (t4)(8 weeks)
- Evaluation of Anxiety and Depression variation after 4 weeks of treatment (t4)(4 weeks)
- Measurement of Quality of Life variation after 4 weeks of follow-up (t8)(8 weeks)
- Assessment of Gastrointestinal Symptoms variation after 4 weeks of treatment (t4)(4 weeks)
- Measurement of Quality of Life variation after 4 weeks of treatment (t4)(4 weeks)
- Evaluation of Functional Status variation after 4 weeks of treatment (t4)(4 weeks)
- Physician's Assessment of General Health variation after 4 weeks of treatment (t4)(4 weeks)
- Evaluation of Anxiety and Depression variation after 4 weeks of follow-up (t8)(8 weeks)
- Evaluation of Functional Status variation after 4 weeks of follow-up (t8)(8 weeks)
- Physician's Assessment of General Health variation after 4 weeks of follow-up (t8)(8 weeks)
- Analysis of PBMC and Serum Expression of inflammatory mediators at baseline (t0) and after 4 weeks of treatment (t4)(4 weeks)
- Investigation of Faecal Microbiota Variation after 4 weeks of treatment (t4)(4 weeks)
研究者
Flavio Caprioli
Associate Professor of Gastroenterology
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico