Probiotic Use for Recovery Enhancement From Long COVID-19 (PURE-LC)

Rush

Status and phase: Active, not recruiting; Phase 2

Conditions: Post-Acute COVID-19 Syndrome

Treatments: Drug: Probiotic Agent; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06643299

24082903

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

180 participants in 2 patient groups, including a placebo group

Probiotic Arm

Active Comparator group

Description:

Probiotic pill taken once daily

Treatment:

Drug: Probiotic Agent

Placebo Arm

Placebo Comparator group

Description:

Identical placebo pill taken once daily

Treatment:

Other: Placebo