Investigation of the Use of a Probiotic Supplement in People With Long COVID

Last updated: August 2, 2023
Sponsor: Sheffield Hallam University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Probiotic

Placebo

Clinical Study ID

NCT05975034
ER45883322
  • Ages > 18
  • All Genders

Study Summary

This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.

Eligibility Criteria

Inclusion

Inclusion Criteria: Long COVID defined as National Institute for Health and Care Excellence (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed orsuspected Covid-19 infection).

Exclusion

Exclusion Criteria: Significant co-morbidities - no pre-existing diagnosis of hypertension,diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy orhaematological disorder or current or recent cancer.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Probiotic
Phase:
Study Start date:
June 12, 2023
Estimated Completion Date:
December 11, 2023

Study Description

240 participants with Long COVID will be randomly assigned to either a probiotic or placebo group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for three weeks before the study, and for the last three weeks of the treatment. Participants will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup of 60 participants will attend the laboratory for blood tests, cognitive function tests and gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for two weeks before the study, and for the final two weeks of the study.

Connect with a study center

  • Sheffield Hallam University

    Sheffield, S1 1WB
    United Kingdom

    Active - Recruiting

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