Pre-probiotic Supplementation for Post-covid Fatigue Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Long COVID

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: Experimental
* Dietary Supplement: Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-probiotic<br>One sachet per day during breakfast | Dietary Supplement: Dietary Supplement: Experimental<br>* Combination of pre-probiotic<br>|
| Placebo Comparator: Placebo<br>One sachet per day during breakfast | Dietary Supplement: Dietary Supplement: Placebo<br>* Inert compound<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Time to exhaustion | Running time to exhaustion during incrementaltestontreadmill | Change from baseline time to exhaustion at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prebiotic, Probiotic, Metabolism, Fatigue