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

Primary Purpose

Long COVID

Status
Active
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Dietary Supplement: Experimental
Dietary Supplement: Placebo
Sponsored by
University of Novi Sad, Faculty of Sport and Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Long COVID focused on measuring Prebiotic, Probiotic, Metabolism, Fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Applied Bioenergetics Lab at Faculty of Sport and PE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pre-probiotic

Placebo

Arm Description

One sachet per day during breakfast

One sachet per day during breakfast

Outcomes

Primary Outcome Measures

Fatigue
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)

Secondary Outcome Measures

Brain creatine
Magnetic resonance spectra for brain creatine
Patient-reported symptoms
Scale of symptoms assessed by Visal Analog Scales (VAS)
Time to exhaustion
Running time to exhaustion during incrementaltestontreadmill

Full Information

First Posted
August 25, 2023
Last Updated
August 25, 2023
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
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1. Study Identification

Unique Protocol Identification Number
NCT06013072
Brief Title
Pre-probiotic Supplementation for Post-covid Fatigue Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID
Keywords
Prebiotic, Probiotic, Metabolism, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-probiotic
Arm Type
Experimental
Arm Description
One sachet per day during breakfast
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One sachet per day during breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: Experimental
Intervention Description
Combination of pre-probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: Placebo
Intervention Description
Inert compound
Primary Outcome Measure Information:
Title
Fatigue
Description
Level of fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
Time Frame
Change from baseline fatigue at 3 months
Secondary Outcome Measure Information:
Title
Brain creatine
Description
Magnetic resonance spectra for brain creatine
Time Frame
Change from baseline brain creatine at 3 months
Title
Patient-reported symptoms
Description
Scale of symptoms assessed by Visal Analog Scales (VAS)
Time Frame
Change from baseline fatigue at 3 months
Title
Time to exhaustion
Description
Running time to exhaustion during incrementaltestontreadmill
Time Frame
Change from baseline time to exhaustion at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Applied Bioenergetics Lab at Faculty of Sport and PE
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

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