Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

Long COVID Clinical Trial

— STOPPFATIQUE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06013072
• Other study ID #: 2022-03-23_CFS
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2024
• Source: University of Novi Sad, Faculty of Sport and Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 15, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Long COVID

Intervention

Dietary Supplement:
• Dietary Supplement: Experimental
Combination of pre-probiotic
• Dietary Supplement: Placebo
Inert compound

Locations

Country	Name	City	State
Serbia	Applied Bioenergetics Lab at Faculty of Sport and PE	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)	Change from baseline fatigue at 3 months
Secondary	Brain creatine	Magnetic resonance spectra for brain creatine concentrations	Change from baseline brain creatine concentrations at 3 months
Secondary	Patient-reported symptoms	Scale of symptoms assessed by Visal Analog Scales (VAS), minimum 0 maximum 10; higher scores mean a worse outcome	Change from baseline fatigue at 3 months
Secondary	Time to exhaustion	Running time to exhaustion during incrementaltestontreadmill	Change from baseline time to exhaustion at 3 months