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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-probiotic | Experimental | One sachet per day during breakfast |
|
| Placebo | Placebo Comparator | One sachet per day during breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: Experimental | Dietary Supplement | Combination of pre-probiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI) | Change from baseline fatigue at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Brain creatine | Magnetic resonance spectra for brain creatine concentrations | Change from baseline brain creatine concentrations at 3 months |
| Patient-reported symptoms | Scale of symptoms assessed by Visal Analog Scales (VAS), minimum 0 maximum 10; higher scores mean a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Bioenergetics Lab at Faculty of Sport and PE | Novi Sad | Vojvodina | 21000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39592468 | Derived | Ranisavljev M, Stajer V, Todorovic N, Ostojic J, Cvejic JH, Steinert RE, Ostojic SM. The effects of 3-month supplementation with synbiotic on patient-reported outcomes, exercise tolerance, and brain and muscle metabolism in adult patients with post-COVID-19 chronic fatigue syndrome (STOP-FATIGUE): a randomized Placebo-controlled clinical trial. Eur J Nutr. 2024 Nov 26;64(1):28. doi: 10.1007/s00394-024-03546-0. |
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Data obtained through this study may be provided to qualified researchers with academic interest in long COVID. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Dietary Supplement: Placebo |
| Dietary Supplement |
Inert compound |
|
| Change from baseline fatigue at 3 months |
| Time to exhaustion | Running time to exhaustion during incrementaltestontreadmill | Change from baseline time to exhaustion at 3 months |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |