Probiotic Use for Recovery Enhancement From Long COVID-19

Phase 2Active Not RecruitingNCT06643299

Rush University Medical Center180 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

180

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Probiotic AgentDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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