Long COVID
Conditions
Brief summary
This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.
Detailed description
240 participants with Long COVID will be randomly assigned to either a probiotic or placebo group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for three weeks before the study, and for the last three weeks of the treatment. Participants will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup of 60 participants will attend the laboratory for blood tests, cognitive function tests and gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for two weeks before the study, and for the final two weeks of the study.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic taken daily for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo taken daily for 12 weeks.
Sponsors
Symprove UK
Biomesight
Sheffield Hallam University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).
Intervention model description
Double-blinded randomised trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Long COVID defined as National Institute for Health and Care Excellence (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed or suspected Covid-19 infection). \-
Exclusion criteria
Significant co-morbidities - no pre-existing diagnosis of hypertension, diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy or haematological disorder or current or recent cancer. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue severity scale (FSS) | 12 weeks | 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle |
| FACIT fatigue scale | 12 weeks | Measure that assesses self-reported fatigue and its impact upon daily activities and function |
| EQ-5D-5L | 12 weeks | Multi-attribute generic health status measure |
| Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a | 12 weeks | Evaluation of ability to participate in social roles and activities |
| Ecological Momentary Assessment (EMA) app | 12 weeks | Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cambridge Neuropsychological Test Automated Battery (CANTAB) | 12 weeks | Computer-based cognitive assessment system |
| IBS-SSS | 12 weeks | Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life |
| Analysis of inflammatory markers | 12 weeks | Measurement of cytokines (including IL-8, IL-6) by ELISA |
| 16S rRNA sequencing | 12 weeks | Analysis of the composition and diversity of the gut microbiome |
| Gastrointestinal Symptom Rating Scale | 12 weeks | 15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation |
| MRC Dyspnoea scale | 12 weeks | Assesses the degree of functional disability due to dyspnoea |
| International. Physical Activity Questionnaire (short form) | 12 weeks | Assesses moderate-to-vigorous physical activity and sedentary behaviour |
| Accelerometery data | 12 weeks | Longitudinal measurement of movement |
Countries
United Kingdom
Contacts
Primary ContactCaroline Dalton, PhD
Outcome results
None listed