Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

NCT06013072 | Completed

• 1 other identifier: 2022-03-23_CFS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Keywords

Prebiotic; Probiotic; Metabolism; Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue

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

  Change from baseline fatigue at 3 months

Secondary Outcomes (3)

• Brain creatine

  Change from baseline brain creatine concentrations at 3 months

• Patient-reported symptoms

  Change from baseline fatigue at 3 months

• Time to exhaustion

  Change from baseline time to exhaustion at 3 months

Study Arms (2)

Pre-probiotic

EXPERIMENTAL

One sachet per day during breakfast

Dietary Supplement: Dietary Supplement: Experimental

Placebo

PLACEBO COMPARATOR

One sachet per day during breakfast

Dietary Supplement: Dietary Supplement: Placebo

Interventions

Dietary Supplement: Experimental DIETARY_SUPPLEMENT

Combination of pre-probiotic

Pre-probiotic

Dietary Supplement: Placebo DIETARY_SUPPLEMENT

Inert compound

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 39592468 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 28, 2023
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

SE (1)