Probiotic Use for Recovery Enhancement From Long COVID-19

NCT ID: NCT06643299

Last Updated: 2025-09-03

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-07-31

Brief Summary

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The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID.

Detailed Description

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The goal of this clinical trial is to learn if probiotics can improve symptoms and quality of life in participants with Long COVID. The main questions it aims to answer are:

1. Do probiotics reduce the number and severity of symptoms in those with Long COVID?
2. Do probiotics improve the physical and mental health quality of life in those with Long COVID?
3. Do probiotics improve return to work and daily activities in those with Long COVID?

Researchers will compare probiotics to a placebo (a look-alike substance that contains no probiotics) to see if probiotics work to treat Long COVID.

Participants will take the study medication (placebo or probiotic) for 4 months. They will then cross over (take the other medication) for an additional 4 months. Participants will complete a survey at baseline, 4 months, and 8 months.

Conditions

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Post-Acute COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Probiotic Arm

Probiotic pill taken once daily

Group Type ACTIVE_COMPARATOR

Probiotic Agent

Intervention Type DRUG

BlueBiology: Ultimate Care probiotic pill taken once daily for a four-month period.

Placebo Arm

Identical placebo pill taken once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo produced to be identical in taste and appearance to the probiotic agent, taken once daily for a four-month period.

Interventions

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Probiotic Agent

BlueBiology: Ultimate Care probiotic pill taken once daily for a four-month period.

Intervention Type DRUG

Placebo

Placebo produced to be identical in taste and appearance to the probiotic agent, taken once daily for a four-month period.

Intervention Type OTHER

Other Intervention Names

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BlueBiotics: Ultimate Care

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years who report Long COVID with persistent symptoms at the time of study initiation

Exclusion Criteria

* No longer have symptoms consistent with LC
* Are unable to take the study medication daily
* Are currently pregnant or planning to become pregnant over the course of the study
* Are currently breastfeeding
* Have been diagnosed with an immune-compromising condition
* Are currently taking immunosuppressants
* Do not speak English as a primary language
* Are regularly taking probiotics
* Are enrolled in another Long COVID study with an intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Gottlieb

Professor of Emergency Medicine, Vice Chair of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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24082903

Identifier Type: -

Identifier Source: org_study_id

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