CClinicalTrials.gg
CompletedNCT06643299PURE-LCUpdated Aug 7, 2026

Probiotic Use for Recovery Enhancement From Long COVID-19

A Phase 2 interventional study of Probiotic Agent and Placebo in Post-Acute COVID-19 Syndrome, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Post-Acute COVID-19 Syndrome

Keywords

  • Long COVID
  • Post-Acute Sequelae of COVID
03

In context

Post-Acute COVID-19 Syndrome

520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.

This study's enrollment of 194 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
194 participants (actual)

Study arms

  • Active comparator
    Probiotic Arm

    Probiotic pill taken once daily

    Drug: Probiotic Agent

  • Placebo comparator
    Placebo Arm

    Identical placebo pill taken once daily

    Other: Placebo

Interventions

  • DrugProbiotic Agent

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

    Also known as: BlueBiotics: Ultimate Care

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. Difference in Long COVID Severity

    Defined as the percentage change from moderate-to-severe Long COVID to mild Long COVID using the Long COVID Symptoms and Severity Score (LC-SSS) tool between groups with subgroup analysis by Long COVID trajectory

    Time frame: Baseline, Four, and Eight Months

Secondary outcomes

  1. Difference in LC-SSS Total Score

    Defined as the change in the LC-SSS total score between groups with subgroup analysis by individual symptom scores and Long COVID trajectory

    Time frame: Baseline, Four, and Eight Months

  2. Difference in Quality of Life

    Defined as the change in score for PROMIS-29 physical and mental health and the PROMIS SF-Cognitive Function 8a scale between groups with subgroup analysis by Long COVID trajectory

    Time frame: Baseline, Four, and Eight Months

  3. Difference in Return to Work and Activity

    Defined as the change in the Work Productivity and Activity Impairment tool scores between groups with subgroup analysis by Long COVID trajectory

    Time frame: Baseline, Four, and Eight Months

07

Study locations

1 site
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06643299
Lead sponsor
Rush University Medical Center
Responsible party
Michael Gottlieb (Professor of Emergency Medicine, Vice Chair of Research, Rush University Medical Center) — Principal investigator
First posted
Oct 16, 2024
Start date
May 13, 2025
Primary completion
Jul 2, 2026
Completion
Jul 2, 2026
Last update
Aug 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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