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

U

University of Novi Sad, Faculty of Sport and Physical Education

Status

Completed

Conditions

Long COVID

Treatments

Dietary Supplement: Dietary Supplement: Experimental
Dietary Supplement: Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06013072
2022-03-23_CFS

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups, including a placebo group

Pre-probiotic
Experimental group
Description:
One sachet per day during breakfast
Treatment:
Dietary Supplement: Dietary Supplement: Experimental
Placebo
Placebo Comparator group
Description:
One sachet per day during breakfast
Treatment:
Dietary Supplement: Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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