Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

Not Applicable

Completed

• Conditions: Long COVID

• Registration Number: NCT06013072
• Lead Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue	Change from baseline fatigue at 3 months	Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

Secondary Outcome Measures

Name	Time	Method
Brain creatine	Change from baseline brain creatine concentrations at 3 months	Magnetic resonance spectra for brain creatine concentrations
Time to exhaustion	Change from baseline time to exhaustion at 3 months	Running time to exhaustion during incrementaltestontreadmill
Patient-reported symptoms	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

Trial Locations

Locations (1)

Applied Bioenergetics Lab at Faculty of Sport and PE; 🇷🇸 Novi Sad, Vojvodina, Serbia