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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 or Spanish as a primary language

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Probiotic Arm 		Probiotic pill taken once daily
  • Dietary Supplement: Probiotic Agent
    BlueBiology: Ultimate Care probiotic pill taken once daily for a four-month period.
    Other names:
    • BlueBiotics: Ultimate Care
Placebo Comparator
Placebo Arm 		Identical placebo pill taken once daily
  • Other: Placebo
    Placebo produced to be identical in taste and appearance to the probiotic agent, taken once daily for a four-month period.

Recruiting Locations

More Details

NCT ID
NCT06643299
Status
Not yet recruiting
Sponsor
Rush University Medical Center

Study Contact

Kristyn Gatling, MA
312-952-6615
inspire@rush.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.