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

University of Novi Sad, Faculty of Sport and Physical Education1 site in 1 country32 target enrollmentOctober 1, 2022

ConditionsLong COVID

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Long COVID
Sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Enrollment: 32
Locations: 1
Primary Endpoint: Fatigue
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

January 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Responsible Party

Principal Investigator

Sergej Ostojic

Professor

University of Novi Sad, Faculty of Sport and Physical Education

Eligibility Criteria

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