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

NCT05874089 | Unknown

• 1 other identifier: DELong#3
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Keywords

Long Covid; Fatigue; Gut Microbioma; Dysbiosis; COVID-19; Coronavirus Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Assessment of Fatigue variation after 4 weeks of follow-up (t8)

  8 weeks

• Evaluation of Anxiety and Depression variation after 4 weeks of treatment (t4)

  4 weeks

• Evaluation of Anxiety and Depression variation after 4 weeks of follow-up (t8)

  8 weeks

• Measurement of Quality of Life variation after 4 weeks of treatment (t4)

  4 weeks

• Measurement of Quality of Life variation after 4 weeks of follow-up (t8)

  8 weeks

Study Arms (2)

VSL#3®

ACTIVE COMPARATOR

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

Dietary Supplement: VSL#3®

Placebo

PLACEBO COMPARATOR

Placebo sachets, two sachets per day for 28 days

Dietary Supplement: Placebo

Interventions

VSL#3® DIETARY_SUPPLEMENT

VSL#3® 450 billions/sachets

VSL#3®

Placebo DIETARY_SUPPLEMENT

Placebo sachets with maltose, cornstarch and dioxide

Also known as: Placebo (for VSL#3®)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue; Dysbiosis; COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Flavio Caprioli, MD, PhD

  Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano

  STUDY DIRECTOR

Central Study Contacts

Flavio Caprioli, MD, PhD

CONTACT

+39 02 5503 2141; flavio.caprioli@policlinico.mi.it

Beatrice Marinoni, MD

CONTACT

+39 02 5503 2141; beatrice.marinoni@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinding is achieved by packaging probiotics and placebo in the same sealed and consecutively numbered containers with sachets similar in packaging, smell, and taste. All study participants and on-site study personnel will remain masked for the treatment allocation (randomized controlled trial phase) until database lock and signature of the statistical analysis plan.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Model Details: This is a single-center randomized, double-blind, placebo-controlled trial. Patients will be recruited from Long Covid out-patient Clinics at Policlinico di Milano Hospital (Milan, Italy) and randomly assigned (1:1) to receive VSL#3® or placebo at the dosage of 2 sachets/die for 28 days. Fasting blood samples and feces will be collected before (t0) and after treatment (t4). Primary and secondary outcome will be assessed at baseline (t0), end of treatment (t4) and end of follow-up (t8) using validated questionnaires (i.e. CFS- Chalder Fatigue Scale; HAD- Hospital Anxiety and Depression Scale, SF36 - Short Form Health Survey, Structured Assessment of Gastrointestinal Symptoms Scale - SAGIS; Symptoms Check List 12 - SCL-12; Karnofsky Performance Status - KPS; Visual Analogue Scale- VAS). Subject participation in this study will be approximately 10 weeks, which include 2-weeks screening/run in period, 4-weeks treatment period and 4-weeks follow-up period.

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 24, 2023
• Study Start: November 3, 2022
• Primary Completion: September 3, 2023
• Study Completion: November 3, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

IT (1)