Long COVID
Conditions
Keywords
Prebiotic, Probiotic, Metabolism, Fatigue
Brief summary
The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue syndrome.
Interventions
DIETARY_SUPPLEMENTDietary Supplement: Experimental
Combination of pre-probiotic
DIETARY_SUPPLEMENTDietary Supplement: Placebo
Inert compound
Sponsors
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 65 years * Covid-19 positive test within last 3 months (as documented byvalid PCR or antigentest * Moderate-to-severe fatigue (20-MFI test total score \> 43.5) * At least one of additional covid-19 related symptoms (anosmia,ageusia,breathingdifficulties,lungpain, body aches, headaches, difficulties concentrating etc.)
Exclusion criteria
* Other pulmonary and cardiovascular conditions * History of dietary supplement use during the past 4 weeks * Organic gastrointestinal (GI) disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract. * Bowel surgery or short bowel syndrome. * Medication or supplement which can impact the gut microbiome, including: antibiotics, antimicrobials, or antifungals in the two months * Probiotic or prebiotic supplements in the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Change from baseline fatigue at 3 months | Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain creatine | Change from baseline brain creatine concentrations at 3 months | Magnetic resonance spectra for brain creatine concentrations |
| Patient-reported symptoms | Change from baseline fatigue at 3 months | Scale of symptoms assessed by Visal Analog Scales (VAS), minimum 0 maximum 10; higher scores mean a worse outcome |
| Time to exhaustion | Change from baseline time to exhaustion at 3 months | Running time to exhaustion during incrementaltestontreadmill |
Countries
Serbia
Outcome results
None listed