Synbiotic Therapy for Long COVID Syndrome
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking probiotics, prebiotics, fiber supplements, immunosuppressive or immunomodulatory drugs, and antibiotics at least 30 days before joining the study.
What data supports the effectiveness of the treatment Synbiotic IVS-1 for Long COVID Syndrome?
Is Synbiotic Therapy for Long COVID Syndrome safe for humans?
How is Synbiotic IVS-1 treatment different from other treatments for Long COVID?
Synbiotic IVS-1 is unique because it combines probiotics (beneficial bacteria) and prebiotics (food for these bacteria) to help restore gut health, which may improve immune function and reduce inflammation. This approach is different from other treatments that do not focus on gut microbiota modulation.12348
What is the purpose of this trial?
Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae (PASC) of Severe Acute Respiratory Syndrome-CoronaVirus -2 (SARS-CoV-2). A study performed at Columbia found that plasma levels of the short chain fatty acid (SCFA), butyric acid, remained lower in people with Neuropsychiatric PASC (NP-PASC) than in people with PASC after SAR-CoV-2 infection. Synbiotics improve SCFA levels and are well-tolerated in the general population but have not been studied among people with PASC in the United States. The purpose of this pilot study is to characterize changes in plasma SCFA levels and gut microbiome after treatment with synbiotics and placebo in people with NP-PASC. The intervention will be a mixture of the prebiotic resistant starch and the probiotic Bifidobacterium adolescentis in-vivo selection 1 strain (iVS-1). The placebo will be Maltodextrin.
Research Team
Rupak Shivakoti, PhD, MHS
Principal Investigator
Columbia Universtiy Medical Center
Michael Yin, MD, MS
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for individuals experiencing long-term symptoms after COVID-19, known as Post-COVID Syndrome or Long COVID. Participants should have neuropsychiatric symptoms and will be assessed to ensure their condition aligns with the study's focus on gut health related to post-COVID recovery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the synbiotic therapy or placebo for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Synbiotic IVS-1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor