WHO COVID-19 - Evaluation of the Efficacy of Probiotics to Reduce the Occurrence of Long COVID

NCT05080244 | Completed DMC

• 1 other identifier: 2021-3700-ECR
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

Brief Summary

Probiotics may be considered as an option of treatment for long COVID since they have anti-viral effect, trigger immunomodulation and have low side-effects. This randomized controlled trial aims to reduce the number of patients with long COVID by 25% 90 days after the COVID-19 diagnosis by taking probiotics in a symptomatic population, self-caring at home. During the acute phase of the disease, participants will take two capsules (probiotics or placebo) per day for 10 days and one capsule (probiotics or placebo) per day for the following 15 days. A follow-up will be done twice during the acute phase, 14 days and 28 days after starting to take the investigational product (compliance to treatment, side effects, etc.). At inclusion and at Day14, Day30 and Day90 after the COVID-19 diagnosis, a questionnaire will be administered (COVID-19 symptoms, anxiety, functioning difficulties, etc.) and 2 saliva and 2 stool (viral and microbiota analyzes) self-samples will be performed.

Conditions

COVID-19

Keywords

Long COVID; COVID-19; Sars-CoV-2; Coronavirus; Probiotics

Outcome Measures

Primary Outcomes (1)

• Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19

  COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)

  90 days after the COVID-19 diagnosis.

Secondary Outcomes (3)

• Compare the proportion of patients presenting COVID-19 symptoms and severity of symptoms at D14, D30 and D90 by taking probiotics during the acute phase of COVID-19.

  14,30 and 90 days after the COVID-19 diagnosis.

• Describe the symptoms severity and evolution by study group and baseline characteristics.

  Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis

• Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).

  Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis

Study Arms (2)

Probiotics

EXPERIMENTAL

Two probiotic strains will constitute the experimental arm (Probiotics). Participants will take two capsules per day (one closed capsule to swallow and one open capsule mixed with maple syrup) for 10 days and one closed capsule per day to swallow for the following 15 days. They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Potato starch and magnesium stearate will constitute the comparator arm (Placebo). Participants will take two capsules per day (one closed capsule to swallow and one open capsule mixed with maple syrup) for 10 days and one closed capsule per day to swallow for the following 15 days. They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.

Dietary Supplement: Placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

2 strains 10x10\^9 UFC/capsule

Probiotics

Placebo DIETARY_SUPPLEMENT

Potato starch and magnesium stearate

Placebo

Eligibility Criteria

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

You may qualify if:

• years and over
• Living in Quebec for the next 90 days
• Self-caring at home
• Able to take medication alone
• With access to a phone or to the Internet
• Able to give informed consent

You may not qualify if:

• Allergies to soy, lactose, yeast, maltodextrin, vitamin C, potato starch, magnesium stearate, hypromellose or titanium dioxide
• Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio-corticosteroid therapy, immunosuppressive pathology)
• Was treated with chemo-radio-corticosteroid therapy in the last 6 months
• Has active cancer
• Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant)
• Already participating in another randomized clinical trial
• Is pregnant, expects to become pregnant in the next few months or is breastfeeding
• Has any other condition that would prevent safe participation in the study

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

CIUSSS de L'Estrie-CHUS Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

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

Interventions

Probiotics

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jean-Charles Pasquier, MD, PhD

  CIUSSSE-CHUS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 15, 2021
• Study Start: October 28, 2021
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)