Long COVIDSTOPPFATIQUENCT06013072
Pre-probiotic Supplementation for Post-covid Fatigue Syndrome
A study testing Dietary Supplement: Experimental in people with Long COVID, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Dietary Supplement: Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Oct 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, 21000
About this study
Official title: 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
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.
- Conditions
- Long COVID
- Being tested
- Dietary Supplement: Experimental, Dietary Supplement: Placebo
- Keywords
- Prebiotic, Probiotic, Metabolism, Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: ExperimentalDietary supplement
Combination of pre-probiotic
Dietary Supplement: PlaceboDietary supplement
Inert compound
| Study group | Role | What they receive |
|---|---|---|
| Pre-probiotic | Experimental | One sachet per day during breakfast Receives: Dietary Supplement: Dietary Supplement: Experimental |
| Placebo | Placebo comparator | One sachet per day during breakfast Receives: Dietary Supplement: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
Measured: Change from baseline fatigue at 3 months
Secondary outcomes (3)
Brain creatine
Magnetic resonance spectra for brain creatine concentrations
Measured: 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
Measured: Change from baseline fatigue at 3 months
Time to exhaustion
Running time to exhaustion during incrementaltestontreadmill
Measured: Change from baseline time to exhaustion at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Oct 2022
- Primary completion31 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013072
- Sponsor's protocol ID
- 2022-03-23_CFS
- Acronym
- STOPPFATIQUE
- Status last verified
- Feb 2024
- First submitted
- 25 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39592468
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06013072
- Acronym / sponsor ID
- STOPPFATIQUE / 2022-03-23_CFS
- Conditions
- Long COVID
- Keywords
- Prebiotic, Probiotic, Metabolism, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Novi Sad, Faculty of Sport and Physical EducationUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-probiotic | Experimental | Dietary Supplement: Dietary Supplement: ExperimentalOne sachet per day during breakfast |
| Placebo | Placebo comparator | Dietary Supplement: Dietary Supplement: PlaceboOne sachet per day during breakfast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: ExperimentalCombination of pre-probiotic | Dietary supplement | Pre-probiotic |
| Dietary Supplement: PlaceboInert compound | Dietary supplement | Placebo |
Primary outcome
Fatigue
Time frame: Change from baseline fatigue at 3 months
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
3 secondary outcomes
Brain creatine
Time frame: Change from baseline brain creatine concentrations at 3 months
Patient-reported symptoms
Time frame: Change from baseline fatigue at 3 months
Time to exhaustion
Time frame: Change from baseline time to exhaustion at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 39592468Ranisavljev 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Experimental in people with Long COVID, run by University of Novi Sad, Faculty of Sport and Physical Education at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Change from baseline fatigue at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06013072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.