Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 10:58 PM
Study NCT ID:
NCT05975034
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Use of a Probiotic Supplement in People With Long COVID
Sponsor:
Sheffield Hallam University
Organization:
Study Overview
Official Title:
Investigation of the Use of a Probiotic Supplement in People With Long COVID
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: