STOPPFATIQUE: Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06013072

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Long COVID	Dietary Supplement: Dietary Supplement: Experimental Dietary Supplement: Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fatigue [Change from baseline fatigue at 3 months]
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

Secondary Outcome Measures

Brain creatine [Change from baseline brain creatine at 3 months]
Magnetic resonance spectra for brain creatine
Patient-reported symptoms [Change from baseline fatigue at 3 months]
Scale of symptoms assessed by Visal Analog Scales (VAS)
Time to exhaustion [Change from baseline time to exhaustion at 3 months]
Running time to exhaustion during incrementaltestontreadmill

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Applied Bioenergetics Lab at Faculty of Sport and PE	Novi Sad	Vojvodina	Serbia	21000

Sponsors and Collaborators

University of Novi Sad, Faculty of Sport and Physical Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sergej Ostojic, Professor, University of Novi Sad, Faculty of Sport and Physical Education

ClinicalTrials.gov Identifier:

NCT06013072

Other Study ID Numbers:

2022-03-23_CFS

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sergej Ostojic, Professor, University of Novi Sad, Faculty of Sport and Physical Education

Additional relevant MeSH terms:

Post-Acute COVID-19 Syndrome

Fatigue

Study Results

No Results Posted as of Aug 28, 2023