NCT06013072Completed
Pre-probiotic Supplementation for Post-covid Fatigue Syndrome
The Effects of 3-month Supplementation With a Pre-probiotic on Patient- and Clinician-reported Outcomes, and Brain Tissue Metabolism in Patients With Post-covid Fatigue Syndrome: a Placebo-controlled Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 25 Aug 2023
- Start date
- 1 Oct 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06013072
What you commit to
- Study type: Interventional
- Participants enrolled: 32
- From 1 Oct 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication or supplement which can impact the gut microbiome, including: antibiotics, antimicrobials, or antifungals in the two months
Other illness
- 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.
Other
- Probiotic or prebiotic supplements in the last 4 weeks
Who the study is looking for
- 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.)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Applied Bioenergetics Lab at Faculty of Sport and PE Coordinator of this site? Confirm its status | Novi Sad | Serbia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.