Pre-probiotic Supplementation for Post-covid Fatigue Syndrome (STOPPFATIQUE)

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.

Study Overview

• Status: Completed
• Conditions: Long COVID
• Intervention / Treatment: Dietary supplement: Dietary Supplement: Experimental; Dietary supplement: Dietary Supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-probiotic; One sachet per day during breakfast	Dietary supplement: Dietary Supplement: Experimental; Combination of pre-probiotic
Placebo Comparator: Placebo; One sachet per day during breakfast	Dietary supplement: Dietary Supplement: Placebo; Inert compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)	Change from baseline fatigue at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to exhaustion	Running time to exhaustion during incrementaltestontreadmill	Change from baseline time to exhaustion at 3 months
Brain creatine	Magnetic resonance spectra for brain creatine concentrations	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	Change from baseline fatigue at 3 months

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Prebiotic; Probiotic; Metabolism
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Fatigue; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022-03-23_CFS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No