This study aims to evaluate the effectiveness of VSL#3® in reducing Fatigue and other symptoms in Long Covid Syndrome compared to placebo.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italy
RECRUITINGAssessment of Fatigue variation after 4 weeks of treatment (t4)
To determine if there is a statistically significant variation in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of treatment (t4)
Time frame: 4 weeks
Assessment of Fatigue variation after 4 weeks of follow-up (t8)
To determine if there is a statistically significant difference in the scores on the Chalder Fatigue Scale between the treated group and the placebo group after 4 weeks of follow-up
Time frame: 8 weeks
Evaluation of Anxiety and Depression variation after 4 weeks of treatment (t4)
To determine if there is a statistically significant difference in the scores on the Hospital Anxiety and Depression Scale (HAD) between the treated group and to the placebo group after 4 weeks of treatment
Time frame: 4 weeks
Evaluation of Anxiety and Depression variation after 4 weeks of follow-up (t8)
To determine if there is a statistically significant difference in the scores on the Hospital Anxiety and Depression Scale (HAD) between the treated group and to the placebo group after 4 weeks of follow-up
Time frame: 8 weeks
Measurement of Quality of Life variation after 4 weeks of treatment (t4)
To determine if there is a statistically significant difference in the scores on the Short Form Health Survey (SF)-36 between the treated group and placebo group after 4 weeks of treatment
Time frame: 4 weeks
Measurement of Quality of Life variation after 4 weeks of follow-up (t8)
To determine if there is a statistically significant difference in the scores on the Short Form Health Survey (SF)-36 between the treated group and the placebo group after 4 weeks of follow-up
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Time frame: 8 weeks
Assessment of Gastrointestinal Symptoms variation after 4 weeks of treatment (t4)
To determine if there is a statistically significant difference in the scores on the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) between the placebo group and the treated group after 4 weeks of treatment
Time frame: 4 weeks
Assessment of Gastrointestinal Symptoms variation after4 weeks of follow-up (t8)
To determine if there is a statistically significant difference in the scores on the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) between the placebo group and the treated group after 4 weeks of follow-up
Time frame: 8 weeks
Analysis of Somatization variation after 4 weeks of treatment (t4)
To identify the level of somatization of symptoms by comparing the scores on the SCL-12 for the somatization of Symptom Checklist-90 (SCL-90) between the treated group and the placebo group after 4 weeks of treatment
Time frame: 4 weeks
Analysis of Somatization variation after 4 weeks of treatment (t4)
To identify the level of somatization of symptoms by comparing the scores on the SCL-12 for the somatization of Symptom Checklist-90 (SCL-90) between the treated groups and the placebo group after 4 weeks of follow-up
Time frame: 8 weeks
Evaluation of Functional Status variation after 4 weeks of treatment (t4)
To assess the general functional status of the patients by comparing the scores on the Karnofsky Performance Status (KPS) Scale between the treated group and the placebo group after 4 weeks of treatment
Time frame: 4 weeks
Evaluation of Functional Status variation after 4 weeks of follow-up (t8)
To assess the general functional status of the patients by comparing the scores on the Karnofsky Performance Status (KPS) Scale between the treated group and the placebo group after 4 weeks of follow-up
Time frame: 8 weeks
Physician's Assessment of General Health variation after 4 weeks of treatment (t4)
To determine the physician's evaluation of the patient's general state of health using a visual-analogue scale (VAS) and comparing it between the treated group and the placebo group after 4 weeks of treatment
Time frame: 4 weeks
Physician's Assessment of General Health variation after 4 weeks of follow-up (t8)
To determine the physician's evaluation of the patient's general state of health using a visual-analogue scale (VAS) and comparing it between the treated group and the placebo group after 4 weeks of follow-up
Time frame: 8 weeks
Analysis of PBMC and Serum Expression of inflammatory mediators at baseline (t0) and after 4 weeks of treatment (t4)
Evaluation of multiple cytokines and chemokines in plasma samples and of immune cell phenotypes in peripheral blood mononuclear cells (PBMCs)
Time frame: 4 weeks
Investigation of Faecal Microbiota Variation after 4 weeks of treatment (t4)
To analyze the variation of the bacterial component of the faecal microbiota in terms of alpha and beta diversity and explore its correlation with clinical response on fatigue in both the placebo group and the treated group by using. Shotgun metagenomics and 16S sequencing of faecal samples at baseline and after 4 weeks of treatment (t4) generate serial gut microbial taxonomic and bacterial functional profiles.
Time frame: 4 weeks