Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

NCT ID: NCT06013072

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long COVID

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-probiotic

One sachet per day during breakfast

Group Type EXPERIMENTAL

Dietary Supplement: Experimental

Intervention Type DIETARY_SUPPLEMENT

Combination of pre-probiotic

Placebo

One sachet per day during breakfast

Group Type PLACEBO_COMPARATOR

Dietary Supplement: Placebo

Intervention Type DIETARY_SUPPLEMENT

Inert compound

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Supplement: Experimental

Combination of pre-probiotic

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Placebo

Inert compound

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sergej Ostojic

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, Serbia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Serbia

References

Explore related publications, articles, or registry entries linked to this study.

Ranisavljev M, Stajer V, Todorovic N, Ostojic J, Cvejic JH, Steinert RE, Ostojic SM. The effects of 3-month supplementation with synbiotic on patient-reported outcomes, exercise tolerance, and brain and muscle metabolism in adult patients with post-COVID-19 chronic fatigue syndrome (STOP-FATIGUE): a randomized Placebo-controlled clinical trial. Eur J Nutr. 2024 Nov 26;64(1):28. doi: 10.1007/s00394-024-03546-0.

Reference Type DERIVED
PMID: 39592468 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-03-23_CFS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Creatine Supplementation in Chronic Fatigue Syndrome
NCT02374112 ACTIVE_NOT_RECRUITING NA
Taurine Supplementation in Long COVID
NCT06721949 RECRUITING PHASE2/PHASE3
Acute Sodium Bicarbonate Supplementation in Athletes
NCT03810404 ACTIVE_NOT_RECRUITING PHASE3