Probiotic Use for Recovery Enhancement From Long COVID-19 (PURE-LC)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Other: Placebo; Drug: Probiotic Agent

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic Arm; Probiotic pill taken once daily	Drug: Probiotic Agent; BlueBiology: Ultimate Care probiotic pill taken once daily for a four-month period.; Other Names: BlueBiotics: Ultimate Care
Placebo Comparator: Placebo Arm; Identical placebo pill taken once daily	Other: Placebo; Placebo produced to be identical in taste and appearance to the probiotic agent, taken once daily for a four-month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, Four, and Eight Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, Four, and Eight Months
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	Baseline, Four, and Eight Months
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	Baseline, Four, and Eight Months

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Long COVID; Post-Acute Sequelae of COVID
• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 24082903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No