Pre-probiotic Supplementation for Post-covid Fatigue Syndrome
NCT ID: NCT06013072
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2022-10-01
2024-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Pre-probiotic
One sachet per day during breakfast
Dietary Supplement: Experimental
Combination of pre-probiotic
Placebo
One sachet per day during breakfast
Dietary Supplement: Placebo
Inert compound
Interventions
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Dietary Supplement: Experimental
Combination of pre-probiotic
Dietary Supplement: Placebo
Inert compound
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Novi Sad, Faculty of Sport and Physical Education
OTHER
Responsible Party
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Sergej Ostojic
Professor
Locations
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Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia
Countries
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References
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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.
Other Identifiers
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2022-03-23_CFS
Identifier Type: -
Identifier Source: org_study_id
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