Post-Acute COVID-19 Syndrome
Conditions
Keywords
Long COVID, Post-Acute Sequelae of COVID
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.
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.
Interventions
DRUGProbiotic Agent
BlueBiology: Ultimate Care probiotic pill taken once daily for a four-month period.
OTHERPlacebo
Placebo produced to be identical in taste and appearance to the probiotic agent, taken once daily for a four-month period.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed