Probiotic Use for Recovery Enhancement From Long COVID-19

Phase 2

• Conditions: Post-Acute COVID-19 Syndrome
• Interventions: Drug: Probiotic Agent; Other: Placebo

• Registration Number: NCT06643299
• Lead Sponsor: Rush University Medical Center

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. 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 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 works 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Status Verified: 2025-04
• Study Start: 2025-05-13
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotic Arm	Probiotic Agent	Probiotic pill taken once daily
Placebo Arm	Placebo	Identical placebo pill taken once daily

Primary Outcome Measures

Name	Time	Method
Difference in Long COVID Severity	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 Outcome Measures

Name	Time	Method
Difference in LC-SSS Total Score	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
Difference in Quality of Life	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
Difference in Return to Work and Activity	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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States