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
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
Connect with a study center
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI 20122
ItalyActive - Recruiting
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