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

NCT ID: NCT05975034

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2023-12-11

Brief Summary

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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

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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.

Conditions

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Long COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded randomised trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).

Study Groups

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Probiotic

Participants assigned to the probiotic group.

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Probiotic taken daily for 12 weeks.

Placebo

Participants assigned to the placebo group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo taken daily for 12 weeks.

Interventions

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Probiotic

Probiotic taken daily for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo taken daily for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symprove UK

UNKNOWN

Sponsor Role collaborator

Biomesight

UNKNOWN

Sponsor Role collaborator

Sheffield Hallam University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Dalton, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Hallam University

Locations

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Sheffield Hallam University

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Caroline Dalton, PhD

Role: CONTACT

44-114-225-3695

Facility Contacts

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Caroline Dalton, PhD

Role: primary

44-114-225-3695

Other Identifiers

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ER45883322

Identifier Type: -

Identifier Source: org_study_id

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