long COVID, post-COVID condition long COVID, post-COVID condition
Conditions
Interventions
In this study we will use the synbiotic product Symflora Original® from Vitakruid®. The Symflora Original® includes probiotics (2 x 10^9 CFU) of eight different bacterial strains: Bifidobacterium lact
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Adult aged 18 or aboveConfirmed diagnosis of long-COVID as determined by the evaluation of the post-COVID expertise center.Access to the internet.The ability to provide informed consent.Understanding of the Dutch language.
Exclusion criteria
Exclusion criteria: The inability to provide informed consent.Hypersensitivity to the active ingredients or any of the excipients.The use of local or systemic steroids.Being immunocompromisedA terminal illness.Participation in another study involving investigational or marketed products concomitantly or within four weeks prior to study entry or during the study.Current or recent intake (<6 months) of any probiotic/prebiotic/synbiotic product.Current or recent intake (<6 months) of any antibiotic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are as follows: o Improvement of symptoms related to long-COVID between the start and end of the trial period, assessed using validated questionnaires: ? Fatigue (9-item FSS) ? Post exertional malaise (DSQ-2-PEM) ? Functional capacity (FUNCAP-55) ? Quality of life (EQ-5D-5L) ? Societal participation (USER-P) ? Cognitive function (CFQ) ? Dyspnea (MRC Dyspnea)o Improvement of symptoms related to long-COVID between the start and end of the trial period, based on frequency and severity as reported by the participant: ? Autonomic dysfunction ? Central nervous system symptoms ? Gastrointestinal complaints ? Pulmonary complaints ? Headache | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in lung function abnormalities, assessed with spirometry and diffusion capacity. • Effect of the synbiotic intervention on the intestinal microbiome composition, assessed using shotgun metagenomics sequencing of the fecal samples. • Effect of the synbiotic intervention on the microbiome composition ex vivo, assessed using i-screen technology (TNO). • Effect of the synbiotic intervention on inflammatory markers in blood. • Occurrence of SMURF-1 gene expression in nasal epithelium. • Effect of a SMURF-1 inhibitor (Novartis) on inflammation, assessed ex vivo through nasal samples. | — |
Countries
Netherlands
Contacts
Public ContactJ.M. Blankestijn
Amsterdam UMC
Outcome results
None listed