WHO COVID-19 - Evaluation of the Efficacy of Probiotics to Reduce the Occurrence of Long COVID
NCT05080244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 618
Last updated 2023-11-07
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
Interventions
- DIETARY_SUPPLEMENT
-
Probiotics
2 strains 10x10\^9 UFC/capsule
- DIETARY_SUPPLEMENT
-
Placebo
Potato starch and magnesium stearate
Sponsors & Collaborators
-
Lallemand Health Solutions
collaborator INDUSTRY -
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
lead OTHER
Principal Investigators
-
Jean-Charles Pasquier, MD, PhD · CIUSSSE-CHUS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-28
- Primary Completion
- 2022-12-04
- Completion
- 2022-12-04
Countries
- Canada
Study Locations
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