VSL#3® vs Placebo in the Treatment of Fatigue and Other Symptoms in Long Covid (DELong#3)

Last updated: May 22, 2023
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Treatment

VSL#3®

Placebo

Clinical Study ID

NCT05874089
DELong#3
  • Ages 18-65
  • All Genders

Study Summary

This study aims to evaluate the effectiveness of VSL#3® in reducing Fatigue and other symptoms in Long Covid Syndrome compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18; <65 yo
  • Previous diagnosis of SARS-CoV-2 infection, documented by nasopharyngeal or antigenicmolecular swab;
  • Not currently be in quarantine or isolation;
  • No antibiotics treatment in the 30 days prior to the trial;
  • Chalder Fatigue Scale (in dichotomous form)>=4 possibly associated with signs andsymptoms of Long COVID-19 syndrome: signs and symptoms that develop during or afterSARS-CoV-2 infection, which persist for more than 4 weeks and are not reasonablyexplained otherwise; signs and symptoms include: fatigue, sleep disturbances,cognitive deficits (i.e. brain fogging, loss of concentration and memory, anxiety,depression), strength deficits, arthralgias and myalgias, gastroenterologicalalterations (reduced appetite, nausea, changes in bowel habits, abdominal pain

Exclusion

Exclusion Criteria:

  • Cardiovascular and pulmonary disease with moderately severe organ dysfunction (NYHA>2,Borg scale>=2);
  • Decompensated endocrine and metabolic diseases (child cirrhosis >= B, decompensatedhypo/hyperthyroidism, decompensated hypoadrenalism)
  • Diagnosis of FM, CFS/ME, and/or IBS prior to SARS-CoV-2 infection;
  • Confirmed diagnoses of neurological pathologies, psychiatric diseases and cognitivedisorders prior to SARS-CoV-2 infection;
  • Previous confirmed diagnosis of chronic musculoskeletal pathologies prior to prior toSARS-CoV-2 infection;
  • Refusal to participate in the study / refusal to process personal data;
  • Pregnancy or breastfeeding;
  • Addiction to alcohol or drugs in previous years;
  • Use of other probiotics during the trial;
  • Use of antibiotics during the trial and in the previous 30 days;
  • Substantial change of diet during the trial;
  • Participation in another clinical study in the previous 30 days or previousparticipation in this same trial;
  • Known intolerance/hypersensitivity to the investigational drug or to the excipients ofthe placebo formulation

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: VSL#3®
Phase:
Study Start date:
November 03, 2022
Estimated Completion Date:
November 03, 2023

Study Description

Long Covid syndrome is a chronic condition characterized by persistent symptoms experienced by individuals who have recovered from acute coronavirus disease (COVID-19). Among the various symptoms reported, fatigue stands out as a particularly burdensome and pervasive issue, significantly impacting the quality of life and daily functioning of Long Covid patients. Recent studies report that gut microbiota is altered during acute illness and not restored even after several months from recovery. Based on this evidence, modulation of intestinal microbiota can be considered as a possible therapeutic approach for Long Covid Syndrome. On this basis, the aim of this study is to evaluate efficacy of VSL#3® compared to placebo in reducing Fatigue in Long Covid Symptoms.

Connect with a study center

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, MI 20122
    Italy

    Active - Recruiting

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