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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Long COVID

Treatments: Dietary Supplement: Placebo; Dietary Supplement: VSL#3®

Study type: Interventional

Funder types: Other

Identifiers

NCT05874089

DELong#3

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18; <65 yo
• Previous diagnosis of SARS-CoV-2 infection, documented by nasopharyngeal or antigenic molecular 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 and symptoms of Long COVID-19 syndrome: signs and symptoms that develop during or after SARS-CoV-2 infection, which persist for more than 4 weeks and are not reasonably explained 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, gastroenterological alterations (reduced appetite, nausea, changes in bowel habits, abdominal pain

Exclusion criteria

• Cardiovascular and pulmonary disease with moderately severe organ dysfunction (NYHA>2, Borg scale>=2);
• Decompensated endocrine and metabolic diseases (child cirrhosis >= B, decompensated hypo/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 cognitive disorders prior to SARS-CoV-2 infection;
• Previous confirmed diagnosis of chronic musculoskeletal pathologies prior to prior to SARS-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 previous participation in this same trial;
• Known intolerance/hypersensitivity to the investigational drug or to the excipients of the placebo formulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups, including a placebo group

VSL#3®

Active Comparator group

Description:

VSL#3® 450 billion sachets, two sachets per day (900 billion of bacteria per day) for 28 days

Treatment:

Dietary Supplement: VSL#3®

Placebo

Placebo Comparator group

Description:

Placebo sachets, two sachets per day for 28 days

Treatment:

Dietary Supplement: Placebo