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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Arm | Active Comparator | Probiotic pill taken once daily |
|
| Placebo Arm | Placebo Comparator | Identical placebo pill taken once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Agent | Drug | BlueBiology: Ultimate Care probiotic pill taken once daily for a four-month period. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Placebo | Other | Placebo produced to be identical in taste and appearance to the probiotic agent, taken once daily for a four-month period. |
|
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 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |