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Completed

NCT Number: NCT06013072

Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

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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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fatigue Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)

Exclusion criteria

  • 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

Treatment and study plan

Dietary Supplement: Experimental

Dietary Supplement

Combination of pre-probiotic

Dietary Supplement: Placebo

Dietary Supplement

Inert compound

Primary outcomes

  1. Fatigue

    Time frame: Change from baseline fatigue at 3 months

    Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

Secondary outcomes

  1. Brain creatine

    Time frame: Change from baseline brain creatine concentrations at 3 months

    Magnetic resonance spectra for brain creatine concentrations

  2. Patient-reported symptoms

    Time frame: Change from baseline fatigue at 3 months

    Scale of symptoms assessed by Visal Analog Scales (VAS), minimum 0 maximum 10; higher scores mean a worse outcome

  3. Time to exhaustion

    Time frame: Change from baseline time to exhaustion at 3 months

    Running time to exhaustion during incrementaltestontreadmill

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Registry information

Official study 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

Acronym: STOPPFATIQUE

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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