Probiotic Use for Recovery Enhancement From Long COVID-19

NCT06643299 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 24082903
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Long COVID; Post-Acute Sequelae of COVID

Outcome Measures

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

  Baseline, Four, and Eight Months

Secondary Outcomes (3)

• Difference in LC-SSS Total Score

  Baseline, Four, and Eight Months

• Difference in Quality of Life

  Baseline, Four, and Eight Months

• Difference in Return to Work and Activity

  Baseline, Four, and Eight Months

Study Arms (2)

Probiotic Arm

ACTIVE COMPARATOR

Probiotic pill taken once daily

Drug: Probiotic Agent

Placebo Arm

PLACEBO COMPARATOR

Identical placebo pill taken once daily

Other: Placebo

Interventions

Probiotic Agent DRUG

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

Also known as: BlueBiotics: Ultimate Care

Probiotic Arm

Placebo OTHER

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine, Vice Chair of Research

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: May 13, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)