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

Long COVID Clinical Trial

— DELong#3  

Official title:

The Role of VSL#3® in the Treatment of Fatigue and Other Symptoms in Long Covid-19 Syndrome: a Randomized, Double-blind, Placebo-controlled Study (DELong#3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874089
• Other study ID #: DELong#3
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: November 3, 2023

Study information

• Verified date: May 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Flavio Caprioli, MD, PhD
• Phone: +39 02 5503 2141
• Email: flavio.caprioli[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: November 3, 2023
• Est. primary completion date: September 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Long COVID

Intervention

Dietary Supplement:
• VSL#3®
VSL#3® 450 billions/sachets
• Placebo
Placebo sachets with maltose, cornstarch and dioxide

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment 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)	4 weeks
Secondary	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	8 weeks
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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	4 weeks
Secondary	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	8 weeks
Secondary	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)	4 weeks
Secondary	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.	4 weeks