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

NCT ID: NCT05874089

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2023-11-03

Brief Summary

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

Detailed 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.

Conditions

Long COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VSL#3®

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

Group Type: ACTIVE_COMPARATOR

VSL#3®

Intervention Type: DIETARY_SUPPLEMENT

VSL#3® 450 billions/sachets

Placebo

Placebo sachets, two sachets per day for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo sachets with maltose, cornstarch and dioxide

Interventions

VSL#3®

VSL#3® 450 billions/sachets

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo sachets with maltose, cornstarch and dioxide

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo (for VSL#3®)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Flavio Caprioli

Associate Professor of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavio Caprioli, MD, PhD

Role: STUDY_DIRECTOR

Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano

Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Flavio Caprioli, MD, PhD

Role: CONTACT

flavio.caprioli@policlinico.mi.it

+39 02 5503 2141

Beatrice Marinoni, MD

Role: CONTACT

beatrice.marinoni@unimi.it

+39 02 5503 2141

Facility Contacts

Beatrice Marinoni, MD

Role: primary

beatrice.marinoni@unimi.it

+39 02 5503 2141

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DELong#3

Identifier Type: -

Identifier Source: org_study_id