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

May 22, 2023 updated by: Flavio Caprioli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VSL#3®
VSL#3® 450 billion sachets, two sachets per day (900 billion of bacteria per day) for 28 days
Dietary supplement: VSL#3®
VSL#3® 450 billions/sachets
Placebo Comparator: Placebo
Placebo sachets, two sachets per day for 28 days
Dietary supplement: Placebo
Placebo sachets with maltose, cornstarch and dioxide
Other Names:
  • Placebo (for VSL#3®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Fatigue variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Fatigue variation after 4 weeks of follow-up (t8)
Time Frame: 8 weeks
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
Evaluation of Anxiety and Depression variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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
Evaluation of Anxiety and Depression variation after 4 weeks of follow-up (t8)
Time Frame: 8 weeks
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
Measurement of Quality of Life variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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
Measurement of Quality of Life variation after 4 weeks of follow-up (t8)
Time Frame: 8 weeks
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
Assessment of Gastrointestinal Symptoms variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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
Assessment of Gastrointestinal Symptoms variation after4 weeks of follow-up (t8)
Time Frame: 8 weeks
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
Analysis of Somatization variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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
Analysis of Somatization variation after 4 weeks of treatment (t4)
Time Frame: 8 weeks
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
Evaluation of Functional Status variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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
Evaluation of Functional Status variation after 4 weeks of follow-up (t8)
Time Frame: 8 weeks
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
Physician's Assessment of General Health variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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
Physician's Assessment of General Health variation after 4 weeks of follow-up (t8)
Time Frame: 8 weeks
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
Analysis of PBMC and Serum Expression of inflammatory mediators at baseline (t0) and after 4 weeks of treatment (t4)
Time Frame: 4 weeks
Evaluation of multiple cytokines and chemokines in plasma samples and of immune cell phenotypes in peripheral blood mononuclear cells (PBMCs)
4 weeks
Investigation of Faecal Microbiota Variation after 4 weeks of treatment (t4)
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Study Director: Flavio Caprioli, MD, PhD, Fondazione IRCCS Ca Granda, Ospedale Policlinico di Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2022

Primary Completion (Anticipated)

September 3, 2023

Study Completion (Anticipated)

November 3, 2023

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DELong#3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Long COVID

Clinical Trials on VSL#3®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe