This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Sheffield Hallam University
Sheffield, United Kingdom
RECRUITINGFatigue severity scale (FSS)
9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle
Time frame: 12 weeks
FACIT fatigue scale
Measure that assesses self-reported fatigue and its impact upon daily activities and function
Time frame: 12 weeks
EQ-5D-5L
Multi-attribute generic health status measure
Time frame: 12 weeks
Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a
Evaluation of ability to participate in social roles and activities
Time frame: 12 weeks
Ecological Momentary Assessment (EMA) app
Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)
Time frame: 12 weeks
IBS-SSS
Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life
Time frame: 12 weeks
Gastrointestinal Symptom Rating Scale
15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation
Time frame: 12 weeks
MRC Dyspnoea scale
Assesses the degree of functional disability due to dyspnoea
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 weeks
International. Physical Activity Questionnaire (short form)
Assesses moderate-to-vigorous physical activity and sedentary behaviour
Time frame: 12 weeks
Accelerometery data
Longitudinal measurement of movement
Time frame: 12 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Computer-based cognitive assessment system
Time frame: 12 weeks
16S rRNA sequencing
Analysis of the composition and diversity of the gut microbiome
Time frame: 12 weeks
Analysis of inflammatory markers
Measurement of cytokines (including IL-8, IL-6) by ELISA
Time frame: 12 weeks