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Active, Not Recruiting

NCT Number: NCT06643299

Probiotic Use for Recovery Enhancement From Long COVID-19

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Post-Acute COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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:

  • Do probiotics reduce the number and severity of symptoms in those with Long COVID?
  • Do probiotics improve the physical and mental health quality of life in those with Long COVID?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Agent

Drug

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

Other names: BlueBiotics: Ultimate Care

Placebo

Other

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

Primary outcomes

  1. Difference in Long COVID Severity

    Time frame: Baseline, Four, and Eight Months

    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

Secondary outcomes

  1. Difference in LC-SSS Total Score

    Time frame: Baseline, Four, and Eight Months

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

  2. Difference in Quality of Life

    Time frame: Baseline, Four, and Eight Months

    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

  3. Difference in Return to Work and Activity

    Time frame: Baseline, Four, and Eight Months

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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

PURE-LC - Probiotic Use for Recovery Enhancement From Long COVID

Acronym: PURE-LC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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