Evaluating the Effects of a Fermented Diet on Microbiome Diversity in Individuals With Long COVID
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Gut Microbiome diversity
研究概览
简要总结
The purpose of this study is to evaluate the effects of fermented foods on bacterial gut microbiome diversity of long-COVID subjects.
详细描述
This will be a single-center, longitudinal randomized controlled trial assessing a high fermented food diet intervention among patients with long COVID.
The investigators will adapt the high fermented food diet intervention previously described by Wastyk et al to our population of patients with long COVID. A list of people meeting inclusion criteria who are open to research participation will be generated by the study team members working in the long COVID clinic; eligible patients will be contacted by a different member of the study team (not working in the long COVID clinic).
Participants who agree to take part in the study will be randomized using REDCap into one of two arms, a control arm (no diet intervention), or an intervention arm. 20 participants will be assigned to each group (40 total). The study will consist of 2 in-person visits at baseline and week 13. There will be weekly phone calls during weeks 1 through 12 for participants on the intervention arm; participants in the control arm will be contacted as needed to ensure that they continue to document their diet three days a week.
All participants will provide a total of two stool samples (baseline and week 13), and undergo psychometric evaluation with Hospital Anxiety and Depression Scale (HADS) A/D, Impact of Event Scale - revised (IES-R), Montreal Cognitive Assessment (MoCA)-blind and European Quality of Life 5 Dimensions 5 Level Version (EuroQol-5D-5L) (baseline and week 13). Demographic information on the subjects will also be collected (age, gender, past medical history including mental health diagnoses or cognitive diagnoses, time of COVID infection, etc).
During the baseline visit, the investigators will interview all study participants and ask participants to provide details about their diet and any use of probiotic foods or supplements. All participants will install the food tracking application, Mayo Clinic Diet App, on their personal smart device and will receive instructions on how to use it by a study team member. An account for each participant will be set up by the study team and participants will be given a username and password. The investigators will have access to the data entered. Participants will be instructed to document their food intake at least three days every week, two weekdays and one weekend day as was done in the study by Wastyk et al. After the study, participants may change their password if they would like to continue food tracking.
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
Participants who are randomized to the control group will not be given information on increasing fermented foods
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (> 18 years old)
- •Patients who have long COVID symptoms
- •a. Long COVID will be defined as: i. A previously documented COVID + infection within the last year ii. A presence of neurological symptoms that started within 4 weeks of the COVID infection (fatigue, difficulty concentrating, depression, anxiety) as per CDC definition of Long Covid.
- •Own a smart device capable of downloading a food logging application. Able to understand and document informed consent
- •Seen in the Mayo Clinic long-COVID Clinic within the Department of General Internal Medicine
排除标准
- •History of dementia, moderate or severe cognitive dysfunction, developmental delay, psychotic disorders such as schizophrenia
- •Unable to tolerate oral foods
- •Potential contraindications to a fermented food diet (chronically immunosuppressed including organ transplant recipients)
- •Neutropenic as listed in the "active problems" list in the EMR
- •Undergoing chemotherapy at the time of consent
- •Taking MAOIs at the time of consent.
- •Active uncontrolled inflammatory bowel disease including ulcerative colitis, Crohn's disease, indeterminate colitis, irritable bowel syndrome (moderate or severe), infectious gastroenteritis, colitis or gastritis, Clostridium difficile infection (recurrent), malabsorptive diseases (such as Celiac disease), major surgery of the GI tract with the exception of cholecystectomy and/or appendectomy in the past 5 years, or any major bowel resection at any time.
- •A reported consumption of 2 servings of probiotic fermented food per day in their normal baseline diet.
研究组 & 干预措施
Control
The subjects in the control arm will only complete the baseline and week 13 visits. They will not be asked to make any changes to their diet, only to document their regular diet 3 days a week.
干预措施: Control (Other)
Treatment
Will receive an in-person teaching session delivered by a trained team member including introductory education on microbiome and a description on a variety of probiotic fermented foods commercially available (fermented dairy products, fermented vegetables, fermented non-alcoholic drinks). Participants will be able to choose their own probiotic fermented foods based on this education and taste preference. Subjects will be contacted weekly to ensure they are tolerating and adhering to the study protocol.
干预措施: Fermented foods (Other)
结局指标
主要结局
Gut Microbiome diversity
时间窗: At enrollment and completion of study (12 weeks)
High-dimensional microbiome data representing taxonomic features of the microbiomes will be analyzed to decode the community structure and key components that are associated with the condition of interest
次要结局
- Symptoms of depression and anxiety(At enrollment and completion of study (12 weeks))
- Assessment of quality of life(At enrollment and completion of study (12 weeks))
- Assessment of post-traumatic stress (PTSD) symptoms(At enrollment and completion of the study (12 weeks))
- Assessment of cognition(At enrollment and completion of study (12 weeks))
研究者
Lioudmila Karnatovskaia
Principal Investigator
Mayo Clinic